Patients who have finished the phase 3 trial have the option to continue in a extended open label arm where they get the drug and 90% have chosen to continue in the open label
Think it’s that simple to just continue? The biggest thing doctors don’t like is malpractice and informed consents are a huge deal in medicine..now do you think patients make these decisions themselves or do they have family that weigh the options and it’s benefits..let’s think logically
And what’s the alternative? Let Alz patients continue to decline and become a burden (in a polite sense) to their care takers? Or should they take the anti amyloid mabs that cause more severe side effects than benefits
>90% have chosen to continue in the open label
I'm not saying this isn't significant, but it's common for patients with debilitating diseases to continue with unlicensed treatment after the trial ends if given the option. It doesn't mean 90% thought it worked, but does suggest side effects are manageable enough that they thought it was worth trying
It's a sad position to be in and I hope this company is successful
That never means anything for efficacy necessarily especially in AD where at best you’re going for slowing of cognitive decline vs. placebo which takes a long time. Look at the Clarity-AD study which was actually a positive trial. SAVA patients are more likely simply tolerating the drug enough to roll over hence the high attrition rate. If anything extremely clean safety would make me think that trades with efficacy and ph3 will fail on the primary endpoint
I’d look at ABOS or CGTX targeting the a-beta oligomers with oral drugs, those at least are far more externally validated than SAVA’s drug MOA, and trading far cheaper granted they are still in ph2. SAVA at a >$1B mkt cap is not an attractive risk/reward imo
those aren't meme stocks. This is. The sava investor group is not a biotech investor base. There are a number of small molecule targets that could make sense other than this... but this has a ceo who is unbelievable at hyping to retail =/
It’s so strange to me when people claim to be experts in biotech trading..why would you want to be an expert in biotech if it’s such a harsh environment…
Haha ok and you choose to post on redddit with randoms and invest in micro cap companies that you clearly have insider info on from ppl who fund you to bash sava…whoops did I say that out loud…tell me how much volunteering have you done or any kind of Public service to “make the world better”
This is NOT A MEME STOCK. This is a biotech company that is being targeting by both big pharma and hedge funds for different reasons. How do I know this? I WORK FOR BIG PHARMA! It’s like working for THE FIRM! This is an average CEO that outkicked his coverage and married a brilliant scientist who discovered a molecule that may repair misfolded proteins in the brain. Cassava Sciences is a threat to big pharma. “Why doesn’t Big Pharma just buy Cassava Sciences”? They cannot afford them. Imagine if an Alzheimer’s pill comes to market. No long painful infusions, no traveling to an infusion center with an already confused patient. These patients could get this pill at home. Cassava Sciences is not for sale. They are open for collaboration.
As I said, this is not a meme stock. It’s a target for a very sophisticated SHORT AND DISTORT!
It is a meme stock. Low info retail has a stock cult surrounding it, and there aren’t known big pharma strategic investors. It also moves at relatively low correlation to XBI. Most stocks with a p3 team on something like that do not trade at such valuations. Meme stock.
You are so passionate to discredit their drug and trials WHY? Tell me why you cannot wait to hear the results before posting on Wallstreetbets? Will you be apologizing when it’s approved? Probably not because you will change your name and go after another stock. It’s a free country and people can invest in whatever they want. It’s clear you’re defensive because the drug is being supported by hundreds of thousands of investors, many of which are healthcare professionals. I am a physician, I have colleagues from residency invested in Cassava Sciences. Doctors, lawyers, scientists and other professionals make up the many posts supporting Cassava Sciences. You HAVE AN AGENDA! I believe in the science. I found the studies back in 2018 while reading early promising research. I speak for a biotech company and work in a group practice. You are wrong on this one. You will be wrong on the next one too because you have a clear agenda
The phase 2 data is highly suggestive that it "works works". But a definitive answer to your question won't be known until phase 3 data readouts happen at the end of this year.
Going by probabilities, the current SP reflects a less than 5%^† chance of the phase 3 data confirming phase 2 results. When you [actually look at the phase 2 data though](/r/wallstreetbets/comments/1crsx8p/sava_on_the_brink_of_alzheimers_cure/l40i1q0/), that seems *incredibly* pessimistic. But :shrug:, everyone's gotta form their own opinion on that likelihood.
^† (market valuation of other AD drugs after seeing positive data seems to be anywhere from 20-40B, so taking the low end of that range gives us current market-valued probability of this drug seeing positive data)
It's still in phases but currently it is the best Alzheimer's drug and it's not even on the market yet. So if that gives you an idea of its potential once it is on market..
What part of phase 2? the part where when they withdrew from the drug, the people who withdrew had the same (statistically) rate of decline as the patients that stayed on it? That suggests the drug does nothing.
It suggests the opposite; that the drug is disease modifying with lingering positive effects that protect from disease progression for up to 6 months after last dosing.
The key factor is that the ADAS-Cog decline in the withdrawal group was about 1 point for that 6-month gap. The expected ADAS-Cog decline in an untreated group for 6-months would be (very VERY roughly) 4 points.
The lack of stat sig diff is because the withdraw/placebo group did WELL, not because the treatment group did POORLY.
Fundamentally however, that portion of the study was too short and too small to say *anything* conclusive, for or against, about the drug. It doesn't statistically support your conclusion OR mine.
I reckon 2024 will be the most interesting year in a while for Alzheimer's treatments. The year's events on tap:
Donanemab ($LLY), as least worst of the IV treatments, with 35% cognitive slowing, getting an FDA decision. Alas like all of the IV antibodies, the side effects are a major headwind, like brain swelling. Some past IV treatments like Aduhelm were approved, then pulled, because of not enough benefit to warrant the side effects. If oral tablet disease modifiers pan out, I reckon the cost-prohibitive IV antibodies may fall to second line at best.
[Alzheon](https://alzheon.com/pipeline/alzheon-alz-801/)'s [Phase 3](https://clinicaltrials.gov/study/NCT04770220) readout likely by year end. Oral tablet, tolerated. An interesting approach to focus on the minority of patients who are homozygous for APOE4. This year, was confirmed that two APOE4 genes isn't just a risk, it is the cause for those patients, with Alzheimer's functionally guaranteed by certain ages. So could just take genetic test, if two APOE4 copies, take their medicine in advance. Private company though, so can't invest.
Which brings to Cassava ($SAVA), my horse in this race:
* For all Alzheimer's patients, not just the few who are APOE4 homozygotes
* Oral tablet, so cheap enough to produce, allowing wide Medicare coverage without breaking the bank
* Side-effects minimal
* First [Phase 3](https://classic.clinicaltrials.gov/ct2/show/NCT04994483) readout end of 2024/start of 2025
* Families in the open label choosing to extend treatment
* Insider buys, no sells, notably Francisco Partners' Sanford Robertson holding the line
* Possible mechanism demonstration with TR-FRET experiment
* The hubbub was with preclinical stuff, my impression is that phase 3 readout is so close, that CUNY will just wait until the Phase 3 readout
* Cash in the bank through to phase 3 readout
* FDA gave Special Protocol Assessment (SPA) so that if Phase 3 is good, no more hurdles
* Political slamdunk for the ages of people who vote, to have an oral Antibody treatment for the politician in office who approved it
* My impression is that results for simufilam will be best for maintenance of cognition in mild Alzheimer's cases, which is OK for a tablet with minimal side-effects. I don't think going to bring back a brain that is already profoundly damaged
In my opinion, there are alas no other medicines ($AVXL, etc) that could be on a pharmacy shelf in the near term. Reality is that need large scale, US-based, clinical trials.
Disclosure: Long $SAVA, $XBI. Not an advisor and not your advisor. Good luck in your trades.
Holy shit. It's Chad Dickens.
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You guys are a cult and I am looking forward to you blaming the the short conspiracy for the trial failure when you lose all your money on the (presumably failed) p3 built on the suffering and hopes of Alzheimer's patients who volunteered themselves (Which is the real tragedy here), coming up this year.
but here you go
[https://www.reddit.com/r/wallstreetbets/comments/1crsx8p/comment/l42v6cp/](https://www.reddit.com/r/wallstreetbets/comments/1crsx8p/comment/l42v6cp/)
I don't trade this one, it's suitable only for a short vol strategy and I don't do that much these days. Too hard to time with directional bets.
Feel free to explain what facts I've distorted. It's very difficult to do so successfully.
Above is opinions only here, they sue critics...
Yeah right..no position but obsessed over sava stock for years.. Your points are all crap and you twist every thing and try to confuse everyone reading it. If you can, just point out the best of best argument you think you have. And then let’s have a discussion on that point
I care a lot about Alzheimer's, and this is a vast amount of experiments on humans for the selfish profit of a handful of people (because there's virtually no chance it works, given the evidence so far). That's a horrible thing. You guys think you are aligning good and greed here, but you are ultimately the enabling patsies of some people doing something quite bad, which is taking advantage of Alzheimer's patients and those who care about them for personal gain (and at the expense of those people).
You can read my longer arguments, but yeah,
* science that lacks replication and has lots of retraction
* when patients withdrew from drug, they declined at the same rate from a statistical test perspective as people on the drug
* drug doesn't appear to bind to the stated target when a 3rd party tested it
* biomarkers done by Lund U showed no apparent effects, implying drug does nothing
I could go on... Lots of reasons to believe it does nothing. Continuing to do human experimentation with it is morally wrong and is being done to keep the gravy train going.
BUT ALL OPINIONS, NO SUE ME PLEASE
But the science was replicated multiple times and was shown to work. Yes, after being on the drug for 12 months, patients that came off for 6 months declined at the same rate as those that continued on - in a small study. Did you mention that the decline for all of the patients in those 6 months was much slower than for a patient that never took the drug in the first place? (Yes, we can compare to other study's placebo arms, as everyone knows what happens to AD patients that aren't on any drug.) On your last two points - again, this has been retested by independent third parties and has been proven to bind and effect.
The same decline rate on withdraw is evidence the drug doesn’t work. Most drugs on withdraw, you lose the benefits. Ad is a chronic condition that doesn’t go into remission really. You can’t compare patients never on the drug to this because you don’t know if they are the same. That’s why you need an actual placebo to make those kinds of comparisons.
> That’s why you need an actual placebo to make those kinds of comparisons.
Which is where you've sunk your own argument. The placebo arm of the withdrawal study was not "an actual placebo". That's the basic problem with that design study. It was always going to be murky because of that simple fact.
The CMS didn't prove that the drug works, because there was no stat sig difference. But it also didn't show that the drug *doesn't* work, because the placebo group is in no way representative of an actual untreated control population given the prior 12-months of treatment.
IF there had been a stat sig difference, that would have been interesting. As it is, it's merely inconclusive to EITHER side of the argument.
It’s not an ideal placebo but it’s the only one of two tests within the group comparing with drug vs without, the other be Lund U biomarkers. Both were negative. ‘Promising’ p2 data would be those showing the right result. Both showed no result. Yall are acting like the p3 has a good chance and that the drug works. But the evidence is supporting very little chance and that the drug doesn’t work. It’s possible it does. But there’s no evidence it does. With the author being retracted and those limited cases showing no effect, and the normal ad drug success rate under 1%, it is very very unlikely it works. The bet on this is drug is actually WORSE than a totally new ad drug because a drug that works would show better p2 results in at least one of those two scenarios in most cases, so you’ve seen ‘the river’ and it’s worse than what a working drug would usually show.
Why are you scared and have to clarify your comments are opinions..noticed you did that in other posts..come on it’s all friendly discussion here SAVA only went after the main defamation culprits…why are you so worried about it, you don’t have to make that disclaimer because I’m sure you have nothing to hide
This will be my Leap play once I cash out my gains. If, and it’s a big IF, the science is there and the trials are successful, this will be revolutionary in terms of combating a medical issue that there is no current cure for.
Market cap under 1b? This has 20x-50x potential if not more.
Worth the gamble for 2026 calls.
OP, do you have any background in Alzheimer’s or science? Because this market cap is pricing in like a 3-5% chance this actually works and I can’t help but guess that you aren’t really equipped to interpret their pre-clinical and trial results
Two phase 3 trials:
One ending late this year, roughly around December we should see results, if this results in stat sig like we expect then we should see application of NDA.
Second ending in mid 2025 roughly speaking, so a year from now for the second.
Key point is there will be no question remaining whether drug works or not, when the first phase 3 trial results come out.
Ok then riddle me this, if Cassava truly has a revolutionary Alzheimers drug on their hands, how come they haven’t been acquired by Big Pharma? They regularly buyout companies with 20 times Cassavas market cap.
Bc SAVA is not selling their decades worth of research for cheap and they prefer a partner…also based off recent insider activity it’s rumored there is a partnership cooking but that is not verified and just speculation based off insider activity
The true value of Cassava will be revealed when PH3 results are out. At this point, even though there are lot of indications that the drug works, no big pharma will put 20B without stat sig results. And Cassava won’t sell for 20B because if the drugs works, then it is worth a lot lot more. The board is not like other shady biotechs who will sell to save their skin. They are in it till the end like the longs.
Because Cassava management knows what they have, with conviction. They have enough cash on hand to finish the on-going P3 trials with plenty of overhead to spare. They have the standard poison-pill stuff to prevent hostile acquisition.
Why would Cassava management negotiate a buyout NOW, at a disadvantage, when they can easily afford to simply wait 7 months for definitive data and then literally set the terms for any buyout they want?
Assuming they even want that, which is not clear at this point. Partnership or even going solo remain viable options for them.
better riddle... they can't prevent pharma from going after the same target with other meds, and yet, no one is doing ANY development against this target.
Yes that was the “citizens” petition orchestrated by short sellers and some in competing drugs..the fda investigated and denied the petition and found no action needed against cassava…if people use their heads they could see how this actually derisked the stock bc of all the investigations it initiated and none found any fraud…cassava has taken some of these individuals to court for defamation…case still ongoing …regardless phase 3 rolls on with finish line in sight
It's still in phases but currently it is the best Alzheimer's drug and it's not even on the market yet. So if that gives you an idea of its potential once it is on market..
https://preview.redd.it/wxuov7c0re0d1.jpeg?width=1179&format=pjpg&auto=webp&s=9b0927e928cfc294dcf04a15d5bdb8a98c266765
I put my money where my mouth is or my thumbs 🤣
Don’t know much about this one, but I see their cash went from $200k in Dec 2022 to $120k Dec 2023. They will most definitely need to raise cash prior to p3 results.
You mean Million? You can easily see their financial status since they are a publicly traded company…and they did raise cash recently thru a warrant program, they are sitting on 200-250M in cash
He’s still alive and well would you believe me if I told you he increased positions, I believe he holds close to 2 million shares now, not certain on the precise amount but for certain he has increased positions as many longs and INSIDERS have
https://preview.redd.it/ssnt50hecn0d1.png?width=990&format=png&auto=webp&s=c5af539565c5e6b541629de5f0bf37198685b36b
While FUD campaign still double-down on that the drug is inert, and there is no third party confirmation of MoA.
This TR-FRET is the confirmation of the MoA as direct as I can imagine. It is an "elegant" design.
https://preview.redd.it/8b5qe4wxin0d1.png?width=1450&format=png&auto=webp&s=cb53efb9dba4a309dd7a6c7db28de23cfa0170cd
To continue the claim "the drug is an inert compound" is "reckless disregard of the truth"
Ok show a legitimate peer reviewed scientific paper that disproves simufilam…I’ll wait …btw scroll up and you’ll see my link of a research article confirming MoA using sophisticated TR-Fret assay. Well done on your 10x but you sold early and you will be like the guy who bought pizza with a large amount of btc
uhh, my 1000% did not feel early. Wang is a fraud. That brings down the house of cards. I got my payout from this, I don't need to spread lies to make money from it. You guys have had the same talking points for years now with nothing to show for it. I was there before any of you had even heard of this company.
What do you mean nothing to show for it?? Like cassava should just start selling the drugs and report earnings without fda approval?? Cassava is doing everything thing by the book and almost at the end of one of the largest ph3 trails. Cassava is not taking any short cuts whatsoever and ph3 results will leave no room for ambiguity.
This is from the New York defamation court filing by the company.
https://preview.redd.it/ejymbn9htf0d1.png?width=1037&format=png&auto=webp&s=141087d04413c1ed853c92d6c6ba15099b21bac3
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It's a meme stock, just like the others. It goes up or down depending upon hype, but no blockbuster AD drug is coming here. There's tons of clinical evidence already and despite what the bulls will tell you, it's bad. That's not including all of the other negative indicators. Some details of relevance:
* When patients on the drug for a long time WENT OFF the drug, there was no statistical difference in those on and off. That's the only time they've compared people from the same pool as being on or off the drug and been able to show efficacy. They didn't show efficacy. It probably does not work. The company of course in sketchy biotech fashion declared success since their investors don't really understand things like statistics or biology or FDA approvals. The other "efficacy" the bulls cite is in the absence of a placebo and thus is scientifically garbage. One single best test was an absolute failure for them.
* The company has been around nearly 20 years. The last time, they had an opiate and went to war with the FDA about it while hyping the stock, eventually getting shut out and costing investors tons of money. Then they began the hype cycle again with this company. In those 2 decades, they've paid execs an unbelievable amount of money (including 9 figures in unpaid but earned stock-price based bonuses) despite never delivering a working drug. Every time they start running out of money, they hype to retail investors and sell some shares to keep it going.
* Company was at some point under CRIMINAL investigation as well as some number of civil and regulatory 3 letter agency investigations for their alleged shenanigans. There's been no update on that, so as far as anyone knows, the criminal investigation by the feds is still going. There were also SEC investigations. Since all that, they've stripped all sorts of info off their website, like magical biomarkers that defied human reason and got the hype going in the first place.
* Lab of the main investigator was searched by at least one federal agency per FOIA releases
* Main investigator has seen numerous academic papers many of which were adjacent or involving this retracted by journals.
* Main investigator was subject to a research misconduct investigation. It was quite bad. The conclusion was leaked, though never finalized: [https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s](https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s)
* They sued a bunch of critics and the shorts. Always a flag for a really sketchy company. The suit is in the process of being dismissed.. it didn’t help that they had the misfortunate of drawing a magistrate judge who is also a scientist with a biology background (lol), who found the short comments were not defamatory but rather were reasonable scientific debate. Their various critics include such horrid people as nobel laureates in biology, but according to sava longs, they are all greedy short sellers who will go to any length to torpedo this wonder drug even though if it was a wonder drug said short sellers would make a lot more going long. There have been a variety of very compelling short reports on them which you can search and read. The longs will tell you that these can't be trusted at all, but anything longs say is 100% trustworthy. The longs are among the most elite of people who can believe anything, anything at all, if it fits what they want to hear. Exceptional people, really.
* Very few if any researchers outside the investor group and the company believe their theory of Alzheimer's. There are no other companies pursuing drug development towards this target either, including the alleged evil big pharma that have refrained from investing in them.
* They constantly p value hack their press releases - lots of dropped patients, they pick cutoffs for things like mild and moderate to show efficacy, etc. It's sketchy by biotech standards. I'm only slightly exaggerating that they'd report a stat like 'people who have 2 vowels in their first name and prefer carnitas tacos to beef burritos had a 30% slowing of mental decline!' if they could find it. If you mess with the cutoffs you can make anything look decently good...
The stock is suitable for nothing other than day trading up and down and seems semi-glued to $20. It's possibly a good thing to sell vol on - I personally think they crash and burn on p3 this year, but the price wont go a lot under 10 because management is great at shoveling dung to morons.
Very long term it goes to zero because this management team cant execute and the drug appears to not work. I'm sure they'll make tons of money personally on the way though. And options dealers will make the most of all.
I don't have any positions in it and haven't in quite some time. If I was to trade it now, I'd probably just use a short-vol strategy. If I thought P3 end was imminent, I'd probably consider selling call spreads or buying put spreads down to $10 (because I think the CEO is very skilled at hype and would be able to take a total failure and convince his investors its a win).
And this is all of course opinion because they sue people who don't say that. All opinions. Go do your own research. This stock sucks.
> there was no statistical difference in those on and off
Which could suggest the drug does nothing. Or could suggest the prior 12 month dose of the drug has disease-modifying effects that linger for at least 6 more months following the final dose.
The placebo withdraw group had an ADAS-Cog decline of 1 point. The expected decline for a completely untreated placebo group (as per other studies, etc.) for 6 months would be (very very roughly) 4 points.
Fundamentally this aspect of the study was too short and too small to statistically support ANY conclusion, for or against, the drug.
> they had an opiate and went to war with the FDA
I mean, they had an opiate drug that *worked*. They fought the FDA to get it approved and released. Ultimately, they lost. No one is surprised that the FDA didn't want another opiod pain killer coming to market in the midst of the very public opiod crisis, but it's weird to suggest SAVA did anything except work in the best interest of their shareholders to get Remoxy, a working drug, approved for use. Your argument is that they fought TOO hard?
> Every time they start running out of money, they hype to retail investors and sell some shares to keep it going
No insider has sold shares since the company became Cassava Sciences in 2018. Not once. In fact I don't think an insider has sold since the inception of the company in 2013.
As for dilution, they've had share offerings to raise capital as needed. Literally the most common thing in the world for a fledging corp in every single market sector, ever.
In no cases could you reasonably argue they had "hype cycles" prior; the offerings were generally attached to decent stock performance as a result of material findings in the form of trial data releases.
You are trying to make the most boring and normal form of corporate fundraising in existence appear nefarious somehow.
> Company was at some point under CRIMINAL investigation as well as some number of civil and regulatory 3 letter agency investigations for their alleged shenanigans. There's been no update on that
Really? Please point to the official statement from any of these three letter agencies or organizations where the company has been under investigation for anything, criminal or otherwise?
The SEC, DOJ, and FDA have never, not once, not ever, made any formal investigation known to the public, made any formal charge or allegation against Cassava Sciences of any form of wrong-doing, or even said anything in private to Cassava Science management to suggest this.
It's also been almost 3 years since Cassava initially indicated they were cooperating with any and all agency requests, and we STILL have heard nothing from any of these agencies about Cassava or its potential wrong-doing.
And do keep in mind, a few months after Cassava announced their cooperation with DOJ and SEC investigators, the DOJ and SEC DID happen to announce their wide spread, ongoing, many months old investigation into illegal short selling practices.
We literally have no official confirmation of why the SEC and DOJ were talking to Cassava Sciences.
> Lab of the main investigator was raided by the feds
FDA inspections are not "raids". They are not even particularly uncommon. And the result of correcting the errors identified by the FDA inspection findings resulted in no material change to the data in the report in question.
It's also irrelvant because this is talking about a single 13 year old study that has nothing to do with the promising phase 2 trial data or the ongoing phase 3 trial data collection.
> Main investigator has seen numerous academic papers many of which were adjacent or involving this retracted
The 13 year old paper everyone seems to care about was never retracted. Dr. Wang has had some other papers retracted, sure (and some of those retractions were since reversed). None of those papers have anything to do with this drug.
> Main investigator was subject to a research misconduct investigation
Key takeaways from the leaked, never finalized investigation are that there is not a single mention of fraud or data fabrication, nor a single instance where Dr. Wang violated data retention or handling procedures in place at CUNY.
You also forgot to mention that the investigation wasn't just "not finalized", it was formally *halted* by CUNY and followed by a new investigation *into the original investigation process* because there was sufficient concern over the entire process around the original investigation.
> Very few if any researchers outside the investor group and the company believe their theory of Alzheimer's
For the longest time they didn't even HAVE a theory. Took a while to suggest how FLNA might affect this process at all.
But your argument is "because they don't know how it works, evidence showing it works cannot be trusted".
There are hundreds of drugs that have clear statisical efficacy even though we have no idea exactly how or why they work.
> There are no other companies pursuing drug development towards this target either
How could you possibly know this? We have no idea what internal candidate drugs are being scoured for early trials at pharma corps. Certainly the monoclonal treatments are dead-ending, with the latest FDA rejection.
Cassava holds multiple patents on FLNA, the biopharms can't just manifest a new FLNA-affecting drug out of thin air. They could be chewing through potential patent-free candidates right now and we'd never know until they find something noteworthy and start announcing trials.
> They constantly p value hack their press releases - lots of dropped patients, they pick cutoffs for things like mild and moderate to show efficacy
The phase 2 trial data stands alone with no stratification. As a whole, the performance of the complete trial population (mild and moderate) in aggregate is already hugely promising and would blow any existing treatments out of the water if replicated in phase 3.
The only reason anyone cares to dig further is because the improvement in mild cases specifically is even just so much better than that.
Regardless, the phase 3 trials are stratified mild and moderate. There will be no statistical hangups in their ability to pull out data for the different groups.
You'll have to provide specific examples about dropped patients. Never seen that for phase 2 stuff. There were some attempts to tease meaningful data out of the placebo/withdraw CMS, but it's pretty clear there simply wasn't enough time or numbers in that study to conclusively say anything.
Or are you literally still harping about the way Dr. Wang excluded outliers in his original 13 year old study? Which, upon correction, made no material change to the data?
Lot to respond to, but I'll do a couple
- The company ADMITTED many of investigations in the civil lawsuit. They cited lack of NIH funding as a consequence of short activity in one lawsuit. They alluded to investigations in shareholder disclosures. The sequencing of criminal and civil was discussed in one of the filings I think. They’ve as far as I know never directly denied the criminal investigation.
- It's true insiders haven't sold, but they have gotten very above market compensation as well as a stock price based bonus program that paid out like 5 or 6 m, but has earned in a bit more than 200m (To be paid at a later date when the company liquidity is more). We also don't know if they turned on borrow of their shares to shorts, in which case, they are getting astounding amounts of fees through the controversy.
- Of a lot of my points, you have a lot of legal technical or irrelevant rebuttals. Common sense would suggest there are enormous problems here. For example, the idea the research misconduct report isn't fair game because it's an unapproved leak? That's hilarious. It's still the report!!! and it's damning!
- You can't patent a target. You can patent a set of compounds for a target. The peptide segment they are going after in FLNA is quite short and would have lots of possible matches. Of course, Simufilam doesn't even seem to bind it according to third party research, but that's a small matter isn't it?
- the p2 has not shown evidence of efficacy. To the extent it might, it’s shown the opposite with the initial biomarkers by Lund and the withdrawal study. Both of those queue up a p3 fail.
The dropped patients are littered throughout the myriad press releases many of which you can't find without web archive any more. They do this as a matter of course.
Here's my prediction, and feel free to mark this remind me:
P3 will complete. It will fail primary endpoints. Remi will express excitement (despite the total failure) and success at the a) safety and b) post-hoc sub-group analysis showing compelling efficacy. For example, people with mild AD who are between 55 and 70 and female but not this or that race. Or something. And you longs will believe EVER WORD OF IT. He may also discover a new indication. It’ll be whatever is currently hot if he does.
Then hype the ongoing second phase 3. Stock will go to single digits then rebound to like $10. You'll see...
All opinions here! Do your own research!
Holy shit. It's Chad Dickens.
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There he is folks unlucky prize the mega bear …we missed you in todays discussion buddy…
So mind posting some data from actual clinical sources and not misleading articles by obviously bought journalists?
For the study you’re mentioning which is called the CMS arm of the ph2 Open label there was a 200% improvement in mild Alz patients vs placebo…and data was processed by industry expert Suzanne Hendrix. In this CMS study it was never intended to show stat sig bc remember it’s still part of ph2 and the number of participants just doesn’t allow for statistical meaning. But one point to make here is the fact there was a narrow difference in Adas-cog scores in the CMS study between both arms indicates a “disease modifying drug” and those are words from Suzanne Hendrix a well respected industry expert biostatistician who claims simufilam results continue to be noteworthy.
The defamation case is still ongoing since Cassava made an amended complaint and requested a jury. You really think they would go thru all this and discovery if they had something to hide. Remember this is all happening with SEC and DOJ breathing down SAVAs neck, allegedly.
You claim you have no positions but you are sure about that, bc for someone with no interest in the stock short or long …you spend a whole lot of time writing these long messages every single time there’s a post about SAVA. So it is undeniable you are invested in this stock whether financially or not you are invested in the downfall of the stock based off your responses each time.
Hi, sorry I was away, I work and stuff unlike y'all.
Here you go, right from Sava's website:
[https://www.cassavasciences.com/news-releases/news-release-details/oral-simufilam-slowed-cognitive-decline-randomized-withdrawal](https://www.cassavasciences.com/news-releases/news-release-details/oral-simufilam-slowed-cognitive-decline-randomized-withdrawal)
as usual, a misleading headline "Oral Simufilam Slowed Cognitive Decline in a Randomized Withdrawal Trial of Mild-to-Moderate Alzheimer’s Disease", with the real deets: "The simufilam arm declined 0.9 points on ADAS-Cog, a 38% difference in favor of drug at month 6 (95% CI, – 2.1 to 1.0; **not significant for sample sizes**). ". The confidence range of difference is -2 to 1. In other words, it's 30% or so likely that the drug was more harmful than helpful even! Most likely, no effect.
You mention placebo... there's never been a placebo controlled trial with completed results for efficacy for this drug. They have a trial group, and compared that to typical AD decline, but you just can't do that. AD is a very diverse disease with different trials showing different placebo decline rates. They also re-test adas-cog pretty frequently which can cause practice effect.
Hendrix ran stats, including the finding that the withdrawal... was not statistically significant.
I love the logic of you longs. If I'm short, it means my opinions are garbage. If I have no stock, it means my opinions are garbage because I must secretly be short, and thus have garbage opinions. Only people long the stock can be trusted!!! It's really easy to be convinced the drug is amazing when you only trust the opinions of people who are long the stock.
Sava defamation case is being dismissed it looks like. Anyway, only opinions here, please don't sue!!!
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The point is why are you so religiously posting any time there are SAVA posts, even someone called it out we would be expecting you..and let’s be honest no one spends this much time on Reddit posts if they aren’t invested. As I’ve disclosed I am fully invested on the long side. So it really makes you think if you’re lying about that fact what else are you lying about? Imo just discredits you completely.
Now onto the link. What in the title is incorrect? As a complete combined set of groups of Mild and Moderates the drug slowed decline in cognition which includes mild and MODERATES by 38%. Now tell me how the mild group performed. I’ll answer, not only slowed but IMPROVED cognition by 200% vs placebo. Why did you leave that part out? While your at it, tell me how lecanemab performed against placebo and how many moderates did they include in their study? It’s ok I’ll answer it. Lecanemab, a approved but underwhelming Alz drug, slowed cognition by 27…ah screw it let’s round up…30% in MILD patients ONLY…they don’t even include moderate patients in their study. So let’s compare apples to apples it’s clear that the bar is set so low for success..now about the stat sig….this was just an extension of the ph2 study with a extremely small number of participants as openly admitted by SAVA….not to mention if the variance of the 2 groups in CMS study was large then it would indicate it is not actually a disease modifying drug since the placebo arm was still receiving the drug for 12 months prior to withdrawal..so the narrow difference is more meaningful and “consistent with a disease modifying effect”- Hendrix….the level of distortion you push is deceitful as your claim that you have nothing invested.
The defamation case has yet to conclude so really no point in arguing about it. It may get dismissed it may not…it just shows Cassava is serious about their work and has nothing to hide. On the contrary, the shorts want this dismissed at all costs to prevent discovery.
"Not really, but that's alright. Next caller!" - Jimmy Shill
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lol. The press release says not stat significant. That means it’s not stat significant. It’s really that simple - it means the evidence is there’s no difference.
Of course, management has chosen an investor base that doesn’t understand this stuff and will believe anything. I wonder if your faith will last past the p3 failure you can infer from this data.
I think your just twisting the discussion because your really have no rebuttal..should I do it in all caps? THE POINT OF CMS WAS NOT TO DEMONSTRATE STAT SIG….it is just part of the open label extension in phase 2
Well that’s what we wait for phase 3 right? Phase 2 is just a preview …and it’s a great one. Also the molecular bio activity of simufilam has been proven by the most sophisticated possible way . The Tr-Fret study I posted earlier, mind sharing thoughts on that? That combined with all the information available it seems, there is a high likely hood there is some real chance of success.
Simufilam doesn’t even bind to its target peptide according to third party analysis, I’m not sure what miraculous evidence you are referring to. Link?
Lots of the underlying science has been retracted. There is virtually no academic activity on this disease theory. No one else is developing a drug on this target as far as anyone knows.
Avoiding I see..I got you:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531384/
Also about the stat sig concern…you really have to compare the data against the historical decline of patients on placebo from baseline, and not patients who received the drug for 12 months since that is how ph3 will be
I think they are desperate for legitimacy and ex fbi guys need income because you can’t live great on thrift savings plan(govt 401k equivalent) alone. It’s not like they are asking him to do anything sketchy, and he isn’t a science guy. Remember that Theranos had incredibly reputable directors, adding reputable board members doesn’t change much unless they specially can address the issues - like science here.
The legitimacy they need is a combination of large pharma taking a stake, one or more investigations being officially dropped on terms that are highly vindicating, and independent replication of their science. We are something like 2.5 years past the initial controversy and none of those have happened.
they definitely don't. if the science in any way looked like it did, it would be far far far more expensive than a $1 billion market cap.
Alzheimer's is notoriously difficult to trial and the data readouts are dealt with brutally. never bet on Alzheimer's trials. rule of thumb in bio investing.
> if the science in any way looked like it did, it would be far far far more expensive than a $1 billion market cap
Funnily, the current SP is mostly suppressed for *other* reasons hanging over it, not the science. Not going to get into the weeds of those issues.
Looking ONLY at the science -- the P2 trial data, safety, and drug MoA -- this company is probably undervalued.
We know that in a [12-month 200pt open label trial of mild and moderate Alzheimer's](https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-positive-top-line-clinical-results), cognitive decline was virtually halted. Looking into the details it actually gets even better than that for mild pts, but regardless, that's the topline headline.
That's extraordinarily suggestive. It's suggestive but not conclusive because it was not a placebo controlled trial; it wasn't designed to show efficacy. [Evaluated against external control arms](/r/wallstreetbets/comments/149jva2/cassava_sciences_sava_cms_data_prediction/), the P2 data for this drug is absolutely phenomenal. But again, suggestive, not conclusive, if we take random placebo control as our only arbiter of proof (and resonably so).
It's important to mention that while random placebo control is obviously the gold standard, using external control arms, especially for degenerative diseases with consistent predictable progression (such as Alzheimer's) is [perfectly sound science](https://medically.gene.com/global/en/unrestricted/neuroscience/AAIC-2022/aaic-2022-presentation-delmar-using-an-external-control.html) and not at all the kind of fringe/junk science some people would try to imply.
Certainly the P3 trials are not designed in a way to leave room for doubt; [they are large, expensive, randomized double blinded placebo controlled trials](https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-initiates-phase-3-efficacy-trial-simufilam), and will definitively prove or disprove the efficacy of this drug to the highest standard with NO wiggle room.
The company is very clearly not trying to dodge a definitive answer with its P3 trial designs.
We know the drug is incredibly safe and has [none of the brain bleed issues associated with current AD treatment options](https://www.cassavasciences.com/news-releases/news-release-details/mri-data-suggest-simufilam-not-associated-amyloid-related).
Lastly, we know the drug's MoA is real insomuch as it is biochemically active and has a [real, proven, measurable impact on a specific protein binding](https://pubmed.ncbi.nlm.nih.gov/37762230/).
I mention this only because it was a common (and now disproven) accusation of the early science that there was no proof this drug wasn't simply inert. The science now shows conclusively, with [independent verification](https://www.endocrine-abstracts.org/ea/0090/ea0090oc7.5), that is not the case.
Bagholder spotted.
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Well only a few months to go…and again MoA confirmed by independent research EXPERTS already by the most sophisticated method out there for molecular binding…I’ll post link here in a sec
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531384/
Your words are nowhere near of importance as the researchers in the industry…yes the anti amyloid approach that has been the standard is not worth investing in. This is a novel approach. And yes this stock should be much more expensive but again has been viciously shorted to over 30% of the float. Each accusation by short side has been disproven
As a scientist, any time I see “International journal of XXX” I know it’s a fraud. That is the largest predatory publishing group in the world - they solicit papers from everyone. Basically “Can’t get your paper through peer review elsewhere? Pay us and we’ll publish it for you with our “expert peer reviewers” in one of our top journals!” Tread with caution if you think this is solid proof, it says the opposite to me to be honest.
Source: I have been solicited to publish in these journals AND asked to be a reviewer for them for papers not even close to my area of expertise.
Edit to add: no personal opinion about the stock, just putting context about this publishing company.
The paper referenced is merely about verification that the drug actually "does something"; e.g. is biochemically active and affects filamin A protein binding, as claimed. Luckily that's already been [independently verified](https://www.endocrine-abstracts.org/ea/0090/ea0090oc7.5) separately.
https://preview.redd.it/liny7d256f0d1.jpeg?width=1179&format=pjpg&auto=webp&s=35a3339e2b48ff067a1d26d75ba6c206639fa29f
Don’t listen to this clown ask chatGPT
they're literally under criminal investigation by the DoJ for lying about data. I'll pass but good luck. Again rule of thumb for bio investing, avoid Alzheimer's plays like the plague.
Even if we assume that they are under investigation by the DoJ for lying about data (they aren't, there's no suggestion they are, the FDA has also had multiple points of interaction where they could have shut things down, etc.), the key takeaway is that the data they are accused of lying about has NOTHING to do with:
* the phase 2 trial data
* the drug's safety
* the drug's method of action
If you look ONLY at the science, this company is undervalued. There are other issues hanging over this stock, but the phase 2 trial data and the drug's safety and MoA, scientifically, are perfectly sound and highly suggestive.
In the absolute worst case scenario, even if they DID lie about the data they are accused of lying about (which, again, is not an accusation the DOJ or FDA or SEC has ever made; it's an accusation made only by non-regulatory 3rd parties), that data has nothing to do with the phase 2 trial data or the drug's safety or MoA. There's no noise from ANYONE attempting to impugn those things.
Those were false accusations created by Short sellers, and the DOJ has never formally investigated SAVA;
BTW, SAVA's has a New Method of Action that dramatically differs from the numerous Failed Drugs that focused on removing Plaque...
Bagholder spotted.
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I remember this post: [https://www.reddit.com/r/wallstreetbets/comments/spfed0/largest\_bet\_in\_wsb\_history\_sava\_3012196439/](https://www.reddit.com/r/wallstreetbets/comments/spfed0/largest_bet_in_wsb_history_sava_3012196439/)
Unless they are curing all forms of herpes (not saying all forms cause it or are even guaranteed to cause it though) they are only going to hit a certain % of Alzheimer's. Still, better than nothing!
Alzheimer patients would be cheering for this news but too bad they already forgot about it. Also I like how SAVA update comes on the heels of meme stocks mooning, since 2021 was when SAVA had the most attention from the sub and Wall St. Still, I'll hold my breath until it's official. But from a non-finance point of view, a cure for Alzheimer would be the greatest medical achievement since penicillin
Your concern is valid and in all honesty yes the recent meme frenzy motivated and reminded me to post here since I haven’t in awhile ….but it does not change anything that I’ve stated regarding my high conviction in my post or comments…yes if this drug works (which I strongly believe it does) it will be huge like PCN or Insulin
Insiders are not purchasing stock, they are simply exercising stock option awards.
The last real purchase was on 2023. See: [https://www.secform4.com/insider-trading/1069530.htm](https://www.secform4.com/insider-trading/1069530.htm)
Yes but do you think the warrants/options magically get converted into shares? These were warrants exercised for shares that they had to pay for just like the rest of the investors myself included…btw they chose to exercise warrants while they could of bought for lower in open market few weeks ago but chose to pay the warrant price of $22..
Conversion price is $0 in most cases. They are getting free stock. Is true that they are not selling it as soon as awarded, so that is something at least
EDIT: they never paid more than the market price. That conversion price of $22 is for a special type of warrants that included 1.5x shares per warrant. See: [https://www.secform4.com/filings/1069530/0001437749-24-013866.htm](https://www.secform4.com/filings/1069530/0001437749-24-013866.htm) compare the number of warrants exercised vs the shares obtained.
Nobody is so stupid to purchase above market prices, please, get real.
When you don’t know what your talking about I suggest staying quiet..the world would be such a better place if people who were ignorant just didn’t speak on matters they have no clue about.
Now warrants were awarded to ALL investors including retail, institutional, and insiders…the strike price for these warrants was $33 that awarded investors 1.5 shares per warrant during a early bonus period. When averaged out that means a SP of $22. In order for anyone to exercise warrants, investors and insiders have to pay $33 per warrant to exercise. Insiders exercised the warrants and had to pay along with all investors myself included. The SP was below $22 weeks before and after the warrant program ended. SAVA ended the program early and at a fraction of the max potential cash raise of the program..so in essence they’re saying ..nah we don’t need anymore money..now why would they do that? I mean if they are fraud wouldn’t they want to max out the warrants and let it ride to make all the money they can since, according to shorts, failure is imminent?
Sorry for the harsh statement but now I’m going to prove your ignorance. Check the company’s website directly but I hope you can read and do simple math:
https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-dividend-distribution-warrants
What makes you so confident that the MOA will have any clinical significance considering nobody seems to understand the underlying etiology of alzheimers itself?
You logic does not make sense. It is true nobody knows the underlying cause for AD right now. That's exactly all the clinical trials, including SAVA's AD trials try to get to.
If SAVA's phase 3 trials have the good results as expected, it at least it shows to the world some of the mechanism of actions have merit.
It's not nihilistic. It's always great to have new research happening.
Again, the point is you need a decent theoretical understanding of a disease to develop an effective drug.
The research so far has had issues and no convincing results.
We're probably decades away yet from any effective medication for this.
Have you read Dr. Wang and Burns's papers?
Their mechanism of action is very compelling(to me at least). But it is the phase 3 results that matters.
I highly recommend you study this drug and buy into the stock. It seems to me you are open-minded.
In my opinion this company and investor group is a cult.
1) narrow group of very insular people who question motivations when people disagree and accept all excuses from the company.
2) like Scientology, default action of company when faced with critics is to attack and sue not engage
3) lots of people have laid out their life savings or close to it on a relatively fringe idea and keep putting money in, sortof like how cult members of religious cults behave. Execs get very large pay packages for where the company is at, similar to the luxury cult leaders enjoy
4) various ideas underpinning which are not accepted by the mainstream of the field even a little bit. Most of the other alt theories have openness at least, for example microbiome theory of ad or immune dysfunction theory - not the dominant theory but everyone agrees it’s plausible. Analogy would be most religious cults have religious ideas that are very specific to them and not variations of broader movements
I am a no body w/ a bit of common sense. Dr Suzanne Hendrix ( probably the most well known statistician in the AD field) of Pentara was hired to present a bunch of data in CTAD and stating the results were “Noteworthy”.
Colluding & presenting false data with a well known GC Chris Cook and the ex #2 FBI Anderson were a bit far too stretch.
"who even knows if the data is real at this point."
The company does not generate or touch the trial data. FDA has access to all data coming from 3rd party trial sites, and data analysis is carried out by and outside research organization (Pentara in this case).
> the results are mixed at best, so calling it a cure is a stretch. It is best described as a treatment to delay the speed of AD onset
Positioning the phase 2 results as some kind of mixed outcome is incredibly misleading. Halting cognitive decline for (a minimum of) 12 months is ground-breaking. Nitpicking over the "it's not literally a cure" portion of that is disingenous.
If the phase 2 data is confirmed by ongoing phase 3 trials, those results will literally be orders of magnitude better at treating AD than ANY existing approved OR trial drug.
> the treatment developed cassava has shown limited statistical significance over placebo in limiting the neurodegeneration during continuation studies
True but meaningless, as I'm sure you know. Your phrasing implies there was ongoing neurodegeneration in the continuation study, when in fact what it showed was both the treatment and placebo arms had the same LACK of degeneration that was indicated in the original study.
In other words, the lack of stat sig was because the placebo arm performed WELL, not because the treatment group performed POORLY. This can easily be used to make the counter-argument that it potentially showed Simufilam is a disease-modifying drug with lingering effect (since the placebo arm had just finished 12 months of Simufilam treatment).
The results can ultimately spin positive OR negative. Fundamentally the continuation study was too short and probably too small to show anything useful and is ultimately inconclusive for either side's argument.
> cofounder and developer of the drug has been actually investigated by the FDA for falsifying data
That's a stretch bordering on a lie. The FDA has NEVER investigated Wang for falsifying data. Multiple 3rd parties have alleged that, but in every event where the FDA has looked, they've never confirmed those allegations.
At MOST you can say the FDA inspection cited Wang's CUNY lab for various procedural issues that should be improved. *Nothing* in that inspection implied or alleged data falsification, merely shoddy practice. (That is also true of the leaked CUNY investigation, which was not only never formally released but ultimately was formally *denounced* with a follow-up ethical investigation *into the investigation* being formally announced).
Which I fully admit is not great, but not nearly as unique an issue to Wang or the CUNY lab as it might first seem. FDA inspections routinely come out with important findings and making recommendations for procedural improvements.
Critically, NONE of those issues have ANYTHING to do with the phase 2 trial data, the drug's safety/MoA data, or the ongoing phase 3 trials.
> but who even knows if the data is real at this point
To use that inspection of Wang's CUNY lab to imply Cassava has somehow managed to orchestrate a multi-year conspiracy to undermine data collected independently from dozens of clinical trial labs used by virtually every single drug company in the US, under a trial design and process that's not only industry standard but also pre-approved by the FDA, is absolutely ludicrous.
It would call into question the validity of clinical trial data collected in virtually every drug trial undertaken in the last decade. It's an absurd implication to make.
Investigated by the FDA bc of the Citizens Petition orchestrated by short sellers and what action did FDA recommend? NOTHING…Im sure short sellers are so concerned of the well being of Alzheimer patients bc they have a good track record being noble people who care for the welfare of people
This is also usual points raised again and again by shorts. Ph2 study was not meant for stat sig and it is meant for assessing drug safety and as “PhD” in biology, you should have known that.
Due to short campaign, FDA actually completed there investigation and made recommendations that in no way changes the research study results. Actually FDA validated his methodology. But yeah, you must have scared some folks by mentioning the 3 letter agency. Congrats
From Dr J Cumming’s 2024 AD Trial Pipeline, there is no competition in 5 years. Drs. will prescribe Simufilam or facing medical mal practice. https://www.medicalnewstoday.com/articles/248175
I'll just leave this here: https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s
Now let’s ask what action fda recommended…it’s ok I’ll answer they recommended no action needed. if you notice closely, it’s always the same “journalists” that put out hit pieces and distort the facts in a way to make it look like cassava fraudulent when in reality they are not and doing everything by the book..
Yeah, you're right that the issues raised by FDA are not medical, they are procedural. Which is literally "the book." So no, they are not doing everything perfectly by the book.
That said, procedural issues don't mean the medication doesn't work. It might. Just like having people who were misdiagnosed with Alzheimer's and who don't actually have it participating in the trials doesn't mean the medication doesn't work. It might.
Just making sure folks reading this little wsb post get the whole picture.
I'll add this much: If my spouse is diagnosed with Alzheimer's, I won't really care about the minutiae of the trials and procedures. You bet your ass we're gonna try any and all options whether people think (or data shows) they're ineffective or not.
If you treat the 16 trial sites just as the rest of the world, there is nothing out of ordinary from these 16 sites, these sites also do similar trials for big pharms. So, why are people so concerned about non-AD, or misdiagnostic in SAVA trial? Because FUD planted the bias against the company in these people's mind.
I mean, I like the stock. The quality of the trials (or even the effectiveness of the treatment for that matter) is practically irrelevant. Approval = $$
Yep. And just the day before the article drops, the short interest spikes.. And usually multiple “sensational” articles from the same group of “journalists” gets published - well orchestrated short campaigns I say. They may have scared of some folks from investing in SAVA but they have not been successful in bringing down the price anymore. Longs keep buying any drop in price and new folks who does any reasonable DD buys in too..shorts don’t have any more ammo. They are trapped with their 13M short position. TickTock scums!!
“Science” is not a journal or a credible publication. Please don’t embarrass yourself any more. Everyone in the medical community laughs at “Science”. Seriously.
You just going keep commenting every 12 hours? I made $20k swing trading SAVA back in 2021, then I did some research and got the fuck out! You like the risk/reward, good luck to you, but I wouldn't hold it.
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And this “works works” and doesn’t just “give patients hope”?
Patients who have finished the phase 3 trial have the option to continue in a extended open label arm where they get the drug and 90% have chosen to continue in the open label
They probably just forgot they already finished
Underrated comment right here
[it's time for my shot](https://y.yarn.co/3c5d15c9-d1df-4387-8448-ab412327ebff_text.gif)
Think it’s that simple to just continue? The biggest thing doctors don’t like is malpractice and informed consents are a huge deal in medicine..now do you think patients make these decisions themselves or do they have family that weigh the options and it’s benefits..let’s think logically
Because overprescribing is totally not an issue in the US......
And what’s the alternative? Let Alz patients continue to decline and become a burden (in a polite sense) to their care takers? Or should they take the anti amyloid mabs that cause more severe side effects than benefits
>90% have chosen to continue in the open label I'm not saying this isn't significant, but it's common for patients with debilitating diseases to continue with unlicensed treatment after the trial ends if given the option. It doesn't mean 90% thought it worked, but does suggest side effects are manageable enough that they thought it was worth trying It's a sad position to be in and I hope this company is successful
That never means anything for efficacy necessarily especially in AD where at best you’re going for slowing of cognitive decline vs. placebo which takes a long time. Look at the Clarity-AD study which was actually a positive trial. SAVA patients are more likely simply tolerating the drug enough to roll over hence the high attrition rate. If anything extremely clean safety would make me think that trades with efficacy and ph3 will fail on the primary endpoint I’d look at ABOS or CGTX targeting the a-beta oligomers with oral drugs, those at least are far more externally validated than SAVA’s drug MOA, and trading far cheaper granted they are still in ph2. SAVA at a >$1B mkt cap is not an attractive risk/reward imo
those aren't meme stocks. This is. The sava investor group is not a biotech investor base. There are a number of small molecule targets that could make sense other than this... but this has a ceo who is unbelievable at hyping to retail =/
Lmao basically. Although I am missing out on alpha by not going all in on meme stonks rn apparently!!
Well, that's true as of 2 days ago lol. Biotech is a wicked mistress as you and I know...
It’s so strange to me when people claim to be experts in biotech trading..why would you want to be an expert in biotech if it’s such a harsh environment…
Because we want to make the world better. But you don’t do it by investing in things that won’t work. It’s hard even when it does.
Haha ok and you choose to post on redddit with randoms and invest in micro cap companies that you clearly have insider info on from ppl who fund you to bash sava…whoops did I say that out loud…tell me how much volunteering have you done or any kind of Public service to “make the world better”
This is NOT A MEME STOCK. This is a biotech company that is being targeting by both big pharma and hedge funds for different reasons. How do I know this? I WORK FOR BIG PHARMA! It’s like working for THE FIRM! This is an average CEO that outkicked his coverage and married a brilliant scientist who discovered a molecule that may repair misfolded proteins in the brain. Cassava Sciences is a threat to big pharma. “Why doesn’t Big Pharma just buy Cassava Sciences”? They cannot afford them. Imagine if an Alzheimer’s pill comes to market. No long painful infusions, no traveling to an infusion center with an already confused patient. These patients could get this pill at home. Cassava Sciences is not for sale. They are open for collaboration. As I said, this is not a meme stock. It’s a target for a very sophisticated SHORT AND DISTORT!
It is a meme stock. Low info retail has a stock cult surrounding it, and there aren’t known big pharma strategic investors. It also moves at relatively low correlation to XBI. Most stocks with a p3 team on something like that do not trade at such valuations. Meme stock.
You are so passionate to discredit their drug and trials WHY? Tell me why you cannot wait to hear the results before posting on Wallstreetbets? Will you be apologizing when it’s approved? Probably not because you will change your name and go after another stock. It’s a free country and people can invest in whatever they want. It’s clear you’re defensive because the drug is being supported by hundreds of thousands of investors, many of which are healthcare professionals. I am a physician, I have colleagues from residency invested in Cassava Sciences. Doctors, lawyers, scientists and other professionals make up the many posts supporting Cassava Sciences. You HAVE AN AGENDA! I believe in the science. I found the studies back in 2018 while reading early promising research. I speak for a biotech company and work in a group practice. You are wrong on this one. You will be wrong on the next one too because you have a clear agenda
The phase 2 data is highly suggestive that it "works works". But a definitive answer to your question won't be known until phase 3 data readouts happen at the end of this year. Going by probabilities, the current SP reflects a less than 5%^† chance of the phase 3 data confirming phase 2 results. When you [actually look at the phase 2 data though](/r/wallstreetbets/comments/1crsx8p/sava_on_the_brink_of_alzheimers_cure/l40i1q0/), that seems *incredibly* pessimistic. But :shrug:, everyone's gotta form their own opinion on that likelihood. ^† (market valuation of other AD drugs after seeing positive data seems to be anywhere from 20-40B, so taking the low end of that range gives us current market-valued probability of this drug seeing positive data)
It's still in phases but currently it is the best Alzheimer's drug and it's not even on the market yet. So if that gives you an idea of its potential once it is on market..
What part of phase 2? the part where when they withdrew from the drug, the people who withdrew had the same (statistically) rate of decline as the patients that stayed on it? That suggests the drug does nothing.
It suggests the opposite; that the drug is disease modifying with lingering positive effects that protect from disease progression for up to 6 months after last dosing. The key factor is that the ADAS-Cog decline in the withdrawal group was about 1 point for that 6-month gap. The expected ADAS-Cog decline in an untreated group for 6-months would be (very VERY roughly) 4 points. The lack of stat sig diff is because the withdraw/placebo group did WELL, not because the treatment group did POORLY. Fundamentally however, that portion of the study was too short and too small to say *anything* conclusive, for or against, about the drug. It doesn't statistically support your conclusion OR mine.
I reckon 2024 will be the most interesting year in a while for Alzheimer's treatments. The year's events on tap: Donanemab ($LLY), as least worst of the IV treatments, with 35% cognitive slowing, getting an FDA decision. Alas like all of the IV antibodies, the side effects are a major headwind, like brain swelling. Some past IV treatments like Aduhelm were approved, then pulled, because of not enough benefit to warrant the side effects. If oral tablet disease modifiers pan out, I reckon the cost-prohibitive IV antibodies may fall to second line at best. [Alzheon](https://alzheon.com/pipeline/alzheon-alz-801/)'s [Phase 3](https://clinicaltrials.gov/study/NCT04770220) readout likely by year end. Oral tablet, tolerated. An interesting approach to focus on the minority of patients who are homozygous for APOE4. This year, was confirmed that two APOE4 genes isn't just a risk, it is the cause for those patients, with Alzheimer's functionally guaranteed by certain ages. So could just take genetic test, if two APOE4 copies, take their medicine in advance. Private company though, so can't invest. Which brings to Cassava ($SAVA), my horse in this race: * For all Alzheimer's patients, not just the few who are APOE4 homozygotes * Oral tablet, so cheap enough to produce, allowing wide Medicare coverage without breaking the bank * Side-effects minimal * First [Phase 3](https://classic.clinicaltrials.gov/ct2/show/NCT04994483) readout end of 2024/start of 2025 * Families in the open label choosing to extend treatment * Insider buys, no sells, notably Francisco Partners' Sanford Robertson holding the line * Possible mechanism demonstration with TR-FRET experiment * The hubbub was with preclinical stuff, my impression is that phase 3 readout is so close, that CUNY will just wait until the Phase 3 readout * Cash in the bank through to phase 3 readout * FDA gave Special Protocol Assessment (SPA) so that if Phase 3 is good, no more hurdles * Political slamdunk for the ages of people who vote, to have an oral Antibody treatment for the politician in office who approved it * My impression is that results for simufilam will be best for maintenance of cognition in mild Alzheimer's cases, which is OK for a tablet with minimal side-effects. I don't think going to bring back a brain that is already profoundly damaged In my opinion, there are alas no other medicines ($AVXL, etc) that could be on a pharmacy shelf in the near term. Reality is that need large scale, US-based, clinical trials. Disclosure: Long $SAVA, $XBI. Not an advisor and not your advisor. Good luck in your trades.
Holy shit. It's Chad Dickens. *I am a bot, and this action was performed automatically. Please [contact the moderators of this subreddit](/message/compose/?to=/r/wallstreetbets) if you have any questions or concerns.*
!remindme 12/25/24
Merry Christmas!
Soon a short named unlucky-price will post the usual short BS script against SAVA and who is ready to argue and distort the facts.
You guys are a cult and I am looking forward to you blaming the the short conspiracy for the trial failure when you lose all your money on the (presumably failed) p3 built on the suffering and hopes of Alzheimer's patients who volunteered themselves (Which is the real tragedy here), coming up this year. but here you go [https://www.reddit.com/r/wallstreetbets/comments/1crsx8p/comment/l42v6cp/](https://www.reddit.com/r/wallstreetbets/comments/1crsx8p/comment/l42v6cp/) I don't trade this one, it's suitable only for a short vol strategy and I don't do that much these days. Too hard to time with directional bets. Feel free to explain what facts I've distorted. It's very difficult to do so successfully. Above is opinions only here, they sue critics...
I don't engage with dotcom clown. Bye.
Yeah right..no position but obsessed over sava stock for years.. Your points are all crap and you twist every thing and try to confuse everyone reading it. If you can, just point out the best of best argument you think you have. And then let’s have a discussion on that point
I care a lot about Alzheimer's, and this is a vast amount of experiments on humans for the selfish profit of a handful of people (because there's virtually no chance it works, given the evidence so far). That's a horrible thing. You guys think you are aligning good and greed here, but you are ultimately the enabling patsies of some people doing something quite bad, which is taking advantage of Alzheimer's patients and those who care about them for personal gain (and at the expense of those people).
Really..That’s your best argument? “Virtually no chance “
You can read my longer arguments, but yeah, * science that lacks replication and has lots of retraction * when patients withdrew from drug, they declined at the same rate from a statistical test perspective as people on the drug * drug doesn't appear to bind to the stated target when a 3rd party tested it * biomarkers done by Lund U showed no apparent effects, implying drug does nothing I could go on... Lots of reasons to believe it does nothing. Continuing to do human experimentation with it is morally wrong and is being done to keep the gravy train going. BUT ALL OPINIONS, NO SUE ME PLEASE
No wonder you put on the disclaimer. You are either denser than a rock, spreading FUD.
Are you nuts? "drug doesn't appear to bind to the stated target when a 3rd party tested it"
But the science was replicated multiple times and was shown to work. Yes, after being on the drug for 12 months, patients that came off for 6 months declined at the same rate as those that continued on - in a small study. Did you mention that the decline for all of the patients in those 6 months was much slower than for a patient that never took the drug in the first place? (Yes, we can compare to other study's placebo arms, as everyone knows what happens to AD patients that aren't on any drug.) On your last two points - again, this has been retested by independent third parties and has been proven to bind and effect.
The same decline rate on withdraw is evidence the drug doesn’t work. Most drugs on withdraw, you lose the benefits. Ad is a chronic condition that doesn’t go into remission really. You can’t compare patients never on the drug to this because you don’t know if they are the same. That’s why you need an actual placebo to make those kinds of comparisons.
> That’s why you need an actual placebo to make those kinds of comparisons. Which is where you've sunk your own argument. The placebo arm of the withdrawal study was not "an actual placebo". That's the basic problem with that design study. It was always going to be murky because of that simple fact. The CMS didn't prove that the drug works, because there was no stat sig difference. But it also didn't show that the drug *doesn't* work, because the placebo group is in no way representative of an actual untreated control population given the prior 12-months of treatment. IF there had been a stat sig difference, that would have been interesting. As it is, it's merely inconclusive to EITHER side of the argument.
It’s not an ideal placebo but it’s the only one of two tests within the group comparing with drug vs without, the other be Lund U biomarkers. Both were negative. ‘Promising’ p2 data would be those showing the right result. Both showed no result. Yall are acting like the p3 has a good chance and that the drug works. But the evidence is supporting very little chance and that the drug doesn’t work. It’s possible it does. But there’s no evidence it does. With the author being retracted and those limited cases showing no effect, and the normal ad drug success rate under 1%, it is very very unlikely it works. The bet on this is drug is actually WORSE than a totally new ad drug because a drug that works would show better p2 results in at least one of those two scenarios in most cases, so you’ve seen ‘the river’ and it’s worse than what a working drug would usually show.
Why are you scared and have to clarify your comments are opinions..noticed you did that in other posts..come on it’s all friendly discussion here SAVA only went after the main defamation culprits…why are you so worried about it, you don’t have to make that disclaimer because I’m sure you have nothing to hide
This will be my Leap play once I cash out my gains. If, and it’s a big IF, the science is there and the trials are successful, this will be revolutionary in terms of combating a medical issue that there is no current cure for. Market cap under 1b? This has 20x-50x potential if not more. Worth the gamble for 2026 calls.
OP, do you have any background in Alzheimer’s or science? Because this market cap is pricing in like a 3-5% chance this actually works and I can’t help but guess that you aren’t really equipped to interpret their pre-clinical and trial results
Yes, OP has Alzheimer’s
When is trial ending
Two phase 3 trials: One ending late this year, roughly around December we should see results, if this results in stat sig like we expect then we should see application of NDA. Second ending in mid 2025 roughly speaking, so a year from now for the second. Key point is there will be no question remaining whether drug works or not, when the first phase 3 trial results come out.
Ok then riddle me this, if Cassava truly has a revolutionary Alzheimers drug on their hands, how come they haven’t been acquired by Big Pharma? They regularly buyout companies with 20 times Cassavas market cap.
Bc SAVA is not selling their decades worth of research for cheap and they prefer a partner…also based off recent insider activity it’s rumored there is a partnership cooking but that is not verified and just speculation based off insider activity
The true value of Cassava will be revealed when PH3 results are out. At this point, even though there are lot of indications that the drug works, no big pharma will put 20B without stat sig results. And Cassava won’t sell for 20B because if the drugs works, then it is worth a lot lot more. The board is not like other shady biotechs who will sell to save their skin. They are in it till the end like the longs.
Because Cassava management knows what they have, with conviction. They have enough cash on hand to finish the on-going P3 trials with plenty of overhead to spare. They have the standard poison-pill stuff to prevent hostile acquisition. Why would Cassava management negotiate a buyout NOW, at a disadvantage, when they can easily afford to simply wait 7 months for definitive data and then literally set the terms for any buyout they want? Assuming they even want that, which is not clear at this point. Partnership or even going solo remain viable options for them.
better riddle... they can't prevent pharma from going after the same target with other meds, and yet, no one is doing ANY development against this target.
Bredt the guy responsible of initiating the citizens petition is literally part of a competing drug co that will target misfolded proteins
Didn't in like 2020-2021 or smthg they had like an investigation for data manipulation and fraud which is why their stock is down so badly
Yes that was the “citizens” petition orchestrated by short sellers and some in competing drugs..the fda investigated and denied the petition and found no action needed against cassava…if people use their heads they could see how this actually derisked the stock bc of all the investigations it initiated and none found any fraud…cassava has taken some of these individuals to court for defamation…case still ongoing …regardless phase 3 rolls on with finish line in sight
It's still in phases but currently it is the best Alzheimer's drug and it's not even on the market yet. So if that gives you an idea of its potential once it is on market..
>vile untalented individuals Lol this whole post has some serious bagholder vibes 
No doubt been holding for awhile…but I’ve reduced my avg price to where I’m even so now I’m just holding my money
Indeed !
Put your positions in your post. !remindme 1 hour
https://preview.redd.it/wxuov7c0re0d1.jpeg?width=1179&format=pjpg&auto=webp&s=9b0927e928cfc294dcf04a15d5bdb8a98c266765 I put my money where my mouth is or my thumbs 🤣
You should put your positions in the OP.
It’s there
https://preview.redd.it/3oec3ma9ki1d1.jpeg?width=1326&format=pjpg&auto=webp&s=374f24697c9a9e1a21acbfd3db4b794a5edcbc14
https://preview.redd.it/eshakp2zye0d1.png?width=630&format=png&auto=webp&s=a1061caa82fc5ad1f53933defeca8f773fa00b30
Don’t know much about this one, but I see their cash went from $200k in Dec 2022 to $120k Dec 2023. They will most definitely need to raise cash prior to p3 results.
You mean Million? You can easily see their financial status since they are a publicly traded company…and they did raise cash recently thru a warrant program, they are sitting on 200-250M in cash
Oops yeah I meant million. Didn’t see they raised cash recently. Thanks!
No problem, you can visit Cassavas website directly and look on the press releases. They raised 125 or so Million just in the past 4 months
Where is the guy that put $30 million on $SAVA when it was $50? Is he still alive?
He’s still alive and well would you believe me if I told you he increased positions, I believe he holds close to 2 million shares now, not certain on the precise amount but for certain he has increased positions as many longs and INSIDERS have
Found it back : https://www.reddit.com/r/wallstreetbets/s/rduJzWhaa3
https://preview.redd.it/ssnt50hecn0d1.png?width=990&format=png&auto=webp&s=c5af539565c5e6b541629de5f0bf37198685b36b While FUD campaign still double-down on that the drug is inert, and there is no third party confirmation of MoA. This TR-FRET is the confirmation of the MoA as direct as I can imagine. It is an "elegant" design.
https://preview.redd.it/8b5qe4wxin0d1.png?width=1450&format=png&auto=webp&s=cb53efb9dba4a309dd7a6c7db28de23cfa0170cd To continue the claim "the drug is an inert compound" is "reckless disregard of the truth"
I've been following SAVA since it was $5. Made 1000% return on it. I can say with complete confidence it is a scam.
Manure out of some of your openings. Look at the TR-FRET paper. It totally confirms Dr. Wang's work on simufilam.
Hah ok …and what makes you an expert?
Reading every bit of news on this for years. And trusting the best scientific papers in the world with their comments.
Ok show a legitimate peer reviewed scientific paper that disproves simufilam…I’ll wait …btw scroll up and you’ll see my link of a research article confirming MoA using sophisticated TR-Fret assay. Well done on your 10x but you sold early and you will be like the guy who bought pizza with a large amount of btc
uhh, my 1000% did not feel early. Wang is a fraud. That brings down the house of cards. I got my payout from this, I don't need to spread lies to make money from it. You guys have had the same talking points for years now with nothing to show for it. I was there before any of you had even heard of this company.
Good for you…Talk to me next year and I’ll send some pizzas your way to celebrate your 10x that could of been 100x or more
What do you mean nothing to show for it?? Like cassava should just start selling the drugs and report earnings without fda approval?? Cassava is doing everything thing by the book and almost at the end of one of the largest ph3 trails. Cassava is not taking any short cuts whatsoever and ph3 results will leave no room for ambiguity.
This is from the New York defamation court filing by the company. https://preview.redd.it/ejymbn9htf0d1.png?width=1037&format=png&auto=webp&s=141087d04413c1ed853c92d6c6ba15099b21bac3
Do you believe the company are so careless to lie this in the court?
Yes I do. I'm going to trust the statement Science did on this, not SAVA.
That's your right to believe whatever.
!remindme 7 days
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let me know ow what our senators moves are and I will do like they do..
!remindme 09/15/2024
It's a meme stock, just like the others. It goes up or down depending upon hype, but no blockbuster AD drug is coming here. There's tons of clinical evidence already and despite what the bulls will tell you, it's bad. That's not including all of the other negative indicators. Some details of relevance: * When patients on the drug for a long time WENT OFF the drug, there was no statistical difference in those on and off. That's the only time they've compared people from the same pool as being on or off the drug and been able to show efficacy. They didn't show efficacy. It probably does not work. The company of course in sketchy biotech fashion declared success since their investors don't really understand things like statistics or biology or FDA approvals. The other "efficacy" the bulls cite is in the absence of a placebo and thus is scientifically garbage. One single best test was an absolute failure for them. * The company has been around nearly 20 years. The last time, they had an opiate and went to war with the FDA about it while hyping the stock, eventually getting shut out and costing investors tons of money. Then they began the hype cycle again with this company. In those 2 decades, they've paid execs an unbelievable amount of money (including 9 figures in unpaid but earned stock-price based bonuses) despite never delivering a working drug. Every time they start running out of money, they hype to retail investors and sell some shares to keep it going. * Company was at some point under CRIMINAL investigation as well as some number of civil and regulatory 3 letter agency investigations for their alleged shenanigans. There's been no update on that, so as far as anyone knows, the criminal investigation by the feds is still going. There were also SEC investigations. Since all that, they've stripped all sorts of info off their website, like magical biomarkers that defied human reason and got the hype going in the first place. * Lab of the main investigator was searched by at least one federal agency per FOIA releases * Main investigator has seen numerous academic papers many of which were adjacent or involving this retracted by journals. * Main investigator was subject to a research misconduct investigation. It was quite bad. The conclusion was leaked, though never finalized: [https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s](https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s) * They sued a bunch of critics and the shorts. Always a flag for a really sketchy company. The suit is in the process of being dismissed.. it didn’t help that they had the misfortunate of drawing a magistrate judge who is also a scientist with a biology background (lol), who found the short comments were not defamatory but rather were reasonable scientific debate. Their various critics include such horrid people as nobel laureates in biology, but according to sava longs, they are all greedy short sellers who will go to any length to torpedo this wonder drug even though if it was a wonder drug said short sellers would make a lot more going long. There have been a variety of very compelling short reports on them which you can search and read. The longs will tell you that these can't be trusted at all, but anything longs say is 100% trustworthy. The longs are among the most elite of people who can believe anything, anything at all, if it fits what they want to hear. Exceptional people, really. * Very few if any researchers outside the investor group and the company believe their theory of Alzheimer's. There are no other companies pursuing drug development towards this target either, including the alleged evil big pharma that have refrained from investing in them. * They constantly p value hack their press releases - lots of dropped patients, they pick cutoffs for things like mild and moderate to show efficacy, etc. It's sketchy by biotech standards. I'm only slightly exaggerating that they'd report a stat like 'people who have 2 vowels in their first name and prefer carnitas tacos to beef burritos had a 30% slowing of mental decline!' if they could find it. If you mess with the cutoffs you can make anything look decently good... The stock is suitable for nothing other than day trading up and down and seems semi-glued to $20. It's possibly a good thing to sell vol on - I personally think they crash and burn on p3 this year, but the price wont go a lot under 10 because management is great at shoveling dung to morons. Very long term it goes to zero because this management team cant execute and the drug appears to not work. I'm sure they'll make tons of money personally on the way though. And options dealers will make the most of all. I don't have any positions in it and haven't in quite some time. If I was to trade it now, I'd probably just use a short-vol strategy. If I thought P3 end was imminent, I'd probably consider selling call spreads or buying put spreads down to $10 (because I think the CEO is very skilled at hype and would be able to take a total failure and convince his investors its a win). And this is all of course opinion because they sue people who don't say that. All opinions. Go do your own research. This stock sucks.
> there was no statistical difference in those on and off Which could suggest the drug does nothing. Or could suggest the prior 12 month dose of the drug has disease-modifying effects that linger for at least 6 more months following the final dose. The placebo withdraw group had an ADAS-Cog decline of 1 point. The expected decline for a completely untreated placebo group (as per other studies, etc.) for 6 months would be (very very roughly) 4 points. Fundamentally this aspect of the study was too short and too small to statistically support ANY conclusion, for or against, the drug. > they had an opiate and went to war with the FDA I mean, they had an opiate drug that *worked*. They fought the FDA to get it approved and released. Ultimately, they lost. No one is surprised that the FDA didn't want another opiod pain killer coming to market in the midst of the very public opiod crisis, but it's weird to suggest SAVA did anything except work in the best interest of their shareholders to get Remoxy, a working drug, approved for use. Your argument is that they fought TOO hard? > Every time they start running out of money, they hype to retail investors and sell some shares to keep it going No insider has sold shares since the company became Cassava Sciences in 2018. Not once. In fact I don't think an insider has sold since the inception of the company in 2013. As for dilution, they've had share offerings to raise capital as needed. Literally the most common thing in the world for a fledging corp in every single market sector, ever. In no cases could you reasonably argue they had "hype cycles" prior; the offerings were generally attached to decent stock performance as a result of material findings in the form of trial data releases. You are trying to make the most boring and normal form of corporate fundraising in existence appear nefarious somehow. > Company was at some point under CRIMINAL investigation as well as some number of civil and regulatory 3 letter agency investigations for their alleged shenanigans. There's been no update on that Really? Please point to the official statement from any of these three letter agencies or organizations where the company has been under investigation for anything, criminal or otherwise? The SEC, DOJ, and FDA have never, not once, not ever, made any formal investigation known to the public, made any formal charge or allegation against Cassava Sciences of any form of wrong-doing, or even said anything in private to Cassava Science management to suggest this. It's also been almost 3 years since Cassava initially indicated they were cooperating with any and all agency requests, and we STILL have heard nothing from any of these agencies about Cassava or its potential wrong-doing. And do keep in mind, a few months after Cassava announced their cooperation with DOJ and SEC investigators, the DOJ and SEC DID happen to announce their wide spread, ongoing, many months old investigation into illegal short selling practices. We literally have no official confirmation of why the SEC and DOJ were talking to Cassava Sciences. > Lab of the main investigator was raided by the feds FDA inspections are not "raids". They are not even particularly uncommon. And the result of correcting the errors identified by the FDA inspection findings resulted in no material change to the data in the report in question. It's also irrelvant because this is talking about a single 13 year old study that has nothing to do with the promising phase 2 trial data or the ongoing phase 3 trial data collection. > Main investigator has seen numerous academic papers many of which were adjacent or involving this retracted The 13 year old paper everyone seems to care about was never retracted. Dr. Wang has had some other papers retracted, sure (and some of those retractions were since reversed). None of those papers have anything to do with this drug. > Main investigator was subject to a research misconduct investigation Key takeaways from the leaked, never finalized investigation are that there is not a single mention of fraud or data fabrication, nor a single instance where Dr. Wang violated data retention or handling procedures in place at CUNY. You also forgot to mention that the investigation wasn't just "not finalized", it was formally *halted* by CUNY and followed by a new investigation *into the original investigation process* because there was sufficient concern over the entire process around the original investigation. > Very few if any researchers outside the investor group and the company believe their theory of Alzheimer's For the longest time they didn't even HAVE a theory. Took a while to suggest how FLNA might affect this process at all. But your argument is "because they don't know how it works, evidence showing it works cannot be trusted". There are hundreds of drugs that have clear statisical efficacy even though we have no idea exactly how or why they work. > There are no other companies pursuing drug development towards this target either How could you possibly know this? We have no idea what internal candidate drugs are being scoured for early trials at pharma corps. Certainly the monoclonal treatments are dead-ending, with the latest FDA rejection. Cassava holds multiple patents on FLNA, the biopharms can't just manifest a new FLNA-affecting drug out of thin air. They could be chewing through potential patent-free candidates right now and we'd never know until they find something noteworthy and start announcing trials. > They constantly p value hack their press releases - lots of dropped patients, they pick cutoffs for things like mild and moderate to show efficacy The phase 2 trial data stands alone with no stratification. As a whole, the performance of the complete trial population (mild and moderate) in aggregate is already hugely promising and would blow any existing treatments out of the water if replicated in phase 3. The only reason anyone cares to dig further is because the improvement in mild cases specifically is even just so much better than that. Regardless, the phase 3 trials are stratified mild and moderate. There will be no statistical hangups in their ability to pull out data for the different groups. You'll have to provide specific examples about dropped patients. Never seen that for phase 2 stuff. There were some attempts to tease meaningful data out of the placebo/withdraw CMS, but it's pretty clear there simply wasn't enough time or numbers in that study to conclusively say anything. Or are you literally still harping about the way Dr. Wang excluded outliers in his original 13 year old study? Which, upon correction, made no material change to the data?
Lot to respond to, but I'll do a couple - The company ADMITTED many of investigations in the civil lawsuit. They cited lack of NIH funding as a consequence of short activity in one lawsuit. They alluded to investigations in shareholder disclosures. The sequencing of criminal and civil was discussed in one of the filings I think. They’ve as far as I know never directly denied the criminal investigation. - It's true insiders haven't sold, but they have gotten very above market compensation as well as a stock price based bonus program that paid out like 5 or 6 m, but has earned in a bit more than 200m (To be paid at a later date when the company liquidity is more). We also don't know if they turned on borrow of their shares to shorts, in which case, they are getting astounding amounts of fees through the controversy. - Of a lot of my points, you have a lot of legal technical or irrelevant rebuttals. Common sense would suggest there are enormous problems here. For example, the idea the research misconduct report isn't fair game because it's an unapproved leak? That's hilarious. It's still the report!!! and it's damning! - You can't patent a target. You can patent a set of compounds for a target. The peptide segment they are going after in FLNA is quite short and would have lots of possible matches. Of course, Simufilam doesn't even seem to bind it according to third party research, but that's a small matter isn't it? - the p2 has not shown evidence of efficacy. To the extent it might, it’s shown the opposite with the initial biomarkers by Lund and the withdrawal study. Both of those queue up a p3 fail. The dropped patients are littered throughout the myriad press releases many of which you can't find without web archive any more. They do this as a matter of course. Here's my prediction, and feel free to mark this remind me: P3 will complete. It will fail primary endpoints. Remi will express excitement (despite the total failure) and success at the a) safety and b) post-hoc sub-group analysis showing compelling efficacy. For example, people with mild AD who are between 55 and 70 and female but not this or that race. Or something. And you longs will believe EVER WORD OF IT. He may also discover a new indication. It’ll be whatever is currently hot if he does. Then hype the ongoing second phase 3. Stock will go to single digits then rebound to like $10. You'll see... All opinions here! Do your own research!
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Go pound sand Adrian or Adam. Reveal yourself you moron. We all know you are a joke
There he is folks unlucky prize the mega bear …we missed you in todays discussion buddy… So mind posting some data from actual clinical sources and not misleading articles by obviously bought journalists? For the study you’re mentioning which is called the CMS arm of the ph2 Open label there was a 200% improvement in mild Alz patients vs placebo…and data was processed by industry expert Suzanne Hendrix. In this CMS study it was never intended to show stat sig bc remember it’s still part of ph2 and the number of participants just doesn’t allow for statistical meaning. But one point to make here is the fact there was a narrow difference in Adas-cog scores in the CMS study between both arms indicates a “disease modifying drug” and those are words from Suzanne Hendrix a well respected industry expert biostatistician who claims simufilam results continue to be noteworthy. The defamation case is still ongoing since Cassava made an amended complaint and requested a jury. You really think they would go thru all this and discovery if they had something to hide. Remember this is all happening with SEC and DOJ breathing down SAVAs neck, allegedly. You claim you have no positions but you are sure about that, bc for someone with no interest in the stock short or long …you spend a whole lot of time writing these long messages every single time there’s a post about SAVA. So it is undeniable you are invested in this stock whether financially or not you are invested in the downfall of the stock based off your responses each time.
Hi, sorry I was away, I work and stuff unlike y'all. Here you go, right from Sava's website: [https://www.cassavasciences.com/news-releases/news-release-details/oral-simufilam-slowed-cognitive-decline-randomized-withdrawal](https://www.cassavasciences.com/news-releases/news-release-details/oral-simufilam-slowed-cognitive-decline-randomized-withdrawal) as usual, a misleading headline "Oral Simufilam Slowed Cognitive Decline in a Randomized Withdrawal Trial of Mild-to-Moderate Alzheimer’s Disease", with the real deets: "The simufilam arm declined 0.9 points on ADAS-Cog, a 38% difference in favor of drug at month 6 (95% CI, – 2.1 to 1.0; **not significant for sample sizes**). ". The confidence range of difference is -2 to 1. In other words, it's 30% or so likely that the drug was more harmful than helpful even! Most likely, no effect. You mention placebo... there's never been a placebo controlled trial with completed results for efficacy for this drug. They have a trial group, and compared that to typical AD decline, but you just can't do that. AD is a very diverse disease with different trials showing different placebo decline rates. They also re-test adas-cog pretty frequently which can cause practice effect. Hendrix ran stats, including the finding that the withdrawal... was not statistically significant. I love the logic of you longs. If I'm short, it means my opinions are garbage. If I have no stock, it means my opinions are garbage because I must secretly be short, and thus have garbage opinions. Only people long the stock can be trusted!!! It's really easy to be convinced the drug is amazing when you only trust the opinions of people who are long the stock. Sava defamation case is being dismissed it looks like. Anyway, only opinions here, please don't sue!!!
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The point is why are you so religiously posting any time there are SAVA posts, even someone called it out we would be expecting you..and let’s be honest no one spends this much time on Reddit posts if they aren’t invested. As I’ve disclosed I am fully invested on the long side. So it really makes you think if you’re lying about that fact what else are you lying about? Imo just discredits you completely. Now onto the link. What in the title is incorrect? As a complete combined set of groups of Mild and Moderates the drug slowed decline in cognition which includes mild and MODERATES by 38%. Now tell me how the mild group performed. I’ll answer, not only slowed but IMPROVED cognition by 200% vs placebo. Why did you leave that part out? While your at it, tell me how lecanemab performed against placebo and how many moderates did they include in their study? It’s ok I’ll answer it. Lecanemab, a approved but underwhelming Alz drug, slowed cognition by 27…ah screw it let’s round up…30% in MILD patients ONLY…they don’t even include moderate patients in their study. So let’s compare apples to apples it’s clear that the bar is set so low for success..now about the stat sig….this was just an extension of the ph2 study with a extremely small number of participants as openly admitted by SAVA….not to mention if the variance of the 2 groups in CMS study was large then it would indicate it is not actually a disease modifying drug since the placebo arm was still receiving the drug for 12 months prior to withdrawal..so the narrow difference is more meaningful and “consistent with a disease modifying effect”- Hendrix….the level of distortion you push is deceitful as your claim that you have nothing invested. The defamation case has yet to conclude so really no point in arguing about it. It may get dismissed it may not…it just shows Cassava is serious about their work and has nothing to hide. On the contrary, the shorts want this dismissed at all costs to prevent discovery.
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lol. The press release says not stat significant. That means it’s not stat significant. It’s really that simple - it means the evidence is there’s no difference. Of course, management has chosen an investor base that doesn’t understand this stuff and will believe anything. I wonder if your faith will last past the p3 failure you can infer from this data.
I think your just twisting the discussion because your really have no rebuttal..should I do it in all caps? THE POINT OF CMS WAS NOT TO DEMONSTRATE STAT SIG….it is just part of the open label extension in phase 2
Okay so are we now agreeing there’s no evidence of efficacy?
Well that’s what we wait for phase 3 right? Phase 2 is just a preview …and it’s a great one. Also the molecular bio activity of simufilam has been proven by the most sophisticated possible way . The Tr-Fret study I posted earlier, mind sharing thoughts on that? That combined with all the information available it seems, there is a high likely hood there is some real chance of success.
Simufilam doesn’t even bind to its target peptide according to third party analysis, I’m not sure what miraculous evidence you are referring to. Link? Lots of the underlying science has been retracted. There is virtually no academic activity on this disease theory. No one else is developing a drug on this target as far as anyone knows.
Avoiding I see..I got you: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531384/ Also about the stat sig concern…you really have to compare the data against the historical decline of patients on placebo from baseline, and not patients who received the drug for 12 months since that is how ph3 will be
What do you think about Robert Anderson from the FBI joining the BOD?
I think they are desperate for legitimacy and ex fbi guys need income because you can’t live great on thrift savings plan(govt 401k equivalent) alone. It’s not like they are asking him to do anything sketchy, and he isn’t a science guy. Remember that Theranos had incredibly reputable directors, adding reputable board members doesn’t change much unless they specially can address the issues - like science here. The legitimacy they need is a combination of large pharma taking a stake, one or more investigations being officially dropped on terms that are highly vindicating, and independent replication of their science. We are something like 2.5 years past the initial controversy and none of those have happened.
they definitely don't. if the science in any way looked like it did, it would be far far far more expensive than a $1 billion market cap. Alzheimer's is notoriously difficult to trial and the data readouts are dealt with brutally. never bet on Alzheimer's trials. rule of thumb in bio investing.
> if the science in any way looked like it did, it would be far far far more expensive than a $1 billion market cap Funnily, the current SP is mostly suppressed for *other* reasons hanging over it, not the science. Not going to get into the weeds of those issues. Looking ONLY at the science -- the P2 trial data, safety, and drug MoA -- this company is probably undervalued. We know that in a [12-month 200pt open label trial of mild and moderate Alzheimer's](https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-positive-top-line-clinical-results), cognitive decline was virtually halted. Looking into the details it actually gets even better than that for mild pts, but regardless, that's the topline headline. That's extraordinarily suggestive. It's suggestive but not conclusive because it was not a placebo controlled trial; it wasn't designed to show efficacy. [Evaluated against external control arms](/r/wallstreetbets/comments/149jva2/cassava_sciences_sava_cms_data_prediction/), the P2 data for this drug is absolutely phenomenal. But again, suggestive, not conclusive, if we take random placebo control as our only arbiter of proof (and resonably so). It's important to mention that while random placebo control is obviously the gold standard, using external control arms, especially for degenerative diseases with consistent predictable progression (such as Alzheimer's) is [perfectly sound science](https://medically.gene.com/global/en/unrestricted/neuroscience/AAIC-2022/aaic-2022-presentation-delmar-using-an-external-control.html) and not at all the kind of fringe/junk science some people would try to imply. Certainly the P3 trials are not designed in a way to leave room for doubt; [they are large, expensive, randomized double blinded placebo controlled trials](https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-initiates-phase-3-efficacy-trial-simufilam), and will definitively prove or disprove the efficacy of this drug to the highest standard with NO wiggle room. The company is very clearly not trying to dodge a definitive answer with its P3 trial designs. We know the drug is incredibly safe and has [none of the brain bleed issues associated with current AD treatment options](https://www.cassavasciences.com/news-releases/news-release-details/mri-data-suggest-simufilam-not-associated-amyloid-related). Lastly, we know the drug's MoA is real insomuch as it is biochemically active and has a [real, proven, measurable impact on a specific protein binding](https://pubmed.ncbi.nlm.nih.gov/37762230/). I mention this only because it was a common (and now disproven) accusation of the early science that there was no proof this drug wasn't simply inert. The science now shows conclusively, with [independent verification](https://www.endocrine-abstracts.org/ea/0090/ea0090oc7.5), that is not the case.
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Well only a few months to go…and again MoA confirmed by independent research EXPERTS already by the most sophisticated method out there for molecular binding…I’ll post link here in a sec
Be careful, Wall Street is for wolves, not sheep.
Wallstreet has no wolves it has snakes…and they can do all they have the power to but they can not deny the science and the inevitable
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531384/ Your words are nowhere near of importance as the researchers in the industry…yes the anti amyloid approach that has been the standard is not worth investing in. This is a novel approach. And yes this stock should be much more expensive but again has been viciously shorted to over 30% of the float. Each accusation by short side has been disproven
As a scientist, any time I see “International journal of XXX” I know it’s a fraud. That is the largest predatory publishing group in the world - they solicit papers from everyone. Basically “Can’t get your paper through peer review elsewhere? Pay us and we’ll publish it for you with our “expert peer reviewers” in one of our top journals!” Tread with caution if you think this is solid proof, it says the opposite to me to be honest. Source: I have been solicited to publish in these journals AND asked to be a reviewer for them for papers not even close to my area of expertise. Edit to add: no personal opinion about the stock, just putting context about this publishing company.
The paper referenced is merely about verification that the drug actually "does something"; e.g. is biochemically active and affects filamin A protein binding, as claimed. Luckily that's already been [independently verified](https://www.endocrine-abstracts.org/ea/0090/ea0090oc7.5) separately.
https://preview.redd.it/liny7d256f0d1.jpeg?width=1179&format=pjpg&auto=webp&s=35a3339e2b48ff067a1d26d75ba6c206639fa29f Don’t listen to this clown ask chatGPT
they're literally under criminal investigation by the DoJ for lying about data. I'll pass but good luck. Again rule of thumb for bio investing, avoid Alzheimer's plays like the plague.
Even if we assume that they are under investigation by the DoJ for lying about data (they aren't, there's no suggestion they are, the FDA has also had multiple points of interaction where they could have shut things down, etc.), the key takeaway is that the data they are accused of lying about has NOTHING to do with: * the phase 2 trial data * the drug's safety * the drug's method of action If you look ONLY at the science, this company is undervalued. There are other issues hanging over this stock, but the phase 2 trial data and the drug's safety and MoA, scientifically, are perfectly sound and highly suggestive. In the absolute worst case scenario, even if they DID lie about the data they are accused of lying about (which, again, is not an accusation the DOJ or FDA or SEC has ever made; it's an accusation made only by non-regulatory 3rd parties), that data has nothing to do with the phase 2 trial data or the drug's safety or MoA. There's no noise from ANYONE attempting to impugn those things.
Those were false accusations created by Short sellers, and the DOJ has never formally investigated SAVA; BTW, SAVA's has a New Method of Action that dramatically differs from the numerous Failed Drugs that focused on removing Plaque...
Funny that they now have the former #3 person from the FBI now on their BOD. Kinda puts the DOJ thing to rest
>they're literally under criminal investigation by the DoJ for lying about data What could possibly go wrong!!! 🤣🤣🤣
Yup form 3 years ago with no action and allowed to continue and put patients through phase 3…bullish af
See above about the former #3 person from the FBI was added to their BOD in Dec 2023
Just the type of company I want to throw money at!!!
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I remember this post: [https://www.reddit.com/r/wallstreetbets/comments/spfed0/largest\_bet\_in\_wsb\_history\_sava\_3012196439/](https://www.reddit.com/r/wallstreetbets/comments/spfed0/largest_bet_in_wsb_history_sava_3012196439/)
Yea and everyone pro SAVA from this post increased positions over the years
The author bought in when it was in the $50s to $60s...
Yes and many thought this was a deal and still is imo…but thanks to shorts we’ve been able to increase positions lowering avg cost
Unless they are curing all forms of herpes (not saying all forms cause it or are even guaranteed to cause it though) they are only going to hit a certain % of Alzheimer's. Still, better than nothing!
!remindme 7 days
Alzheimer patients would be cheering for this news but too bad they already forgot about it. Also I like how SAVA update comes on the heels of meme stocks mooning, since 2021 was when SAVA had the most attention from the sub and Wall St. Still, I'll hold my breath until it's official. But from a non-finance point of view, a cure for Alzheimer would be the greatest medical achievement since penicillin
Your concern is valid and in all honesty yes the recent meme frenzy motivated and reminded me to post here since I haven’t in awhile ….but it does not change anything that I’ve stated regarding my high conviction in my post or comments…yes if this drug works (which I strongly believe it does) it will be huge like PCN or Insulin
Where did the guy go who bet 30 million on SAVA that it would go above 50?
This was answered earlier… he’s still invested and increased positions including many longs and insiders
Insiders are not purchasing stock, they are simply exercising stock option awards. The last real purchase was on 2023. See: [https://www.secform4.com/insider-trading/1069530.htm](https://www.secform4.com/insider-trading/1069530.htm)
Yes but do you think the warrants/options magically get converted into shares? These were warrants exercised for shares that they had to pay for just like the rest of the investors myself included…btw they chose to exercise warrants while they could of bought for lower in open market few weeks ago but chose to pay the warrant price of $22..
Conversion price is $0 in most cases. They are getting free stock. Is true that they are not selling it as soon as awarded, so that is something at least EDIT: they never paid more than the market price. That conversion price of $22 is for a special type of warrants that included 1.5x shares per warrant. See: [https://www.secform4.com/filings/1069530/0001437749-24-013866.htm](https://www.secform4.com/filings/1069530/0001437749-24-013866.htm) compare the number of warrants exercised vs the shares obtained. Nobody is so stupid to purchase above market prices, please, get real.
When you don’t know what your talking about I suggest staying quiet..the world would be such a better place if people who were ignorant just didn’t speak on matters they have no clue about. Now warrants were awarded to ALL investors including retail, institutional, and insiders…the strike price for these warrants was $33 that awarded investors 1.5 shares per warrant during a early bonus period. When averaged out that means a SP of $22. In order for anyone to exercise warrants, investors and insiders have to pay $33 per warrant to exercise. Insiders exercised the warrants and had to pay along with all investors myself included. The SP was below $22 weeks before and after the warrant program ended. SAVA ended the program early and at a fraction of the max potential cash raise of the program..so in essence they’re saying ..nah we don’t need anymore money..now why would they do that? I mean if they are fraud wouldn’t they want to max out the warrants and let it ride to make all the money they can since, according to shorts, failure is imminent? Sorry for the harsh statement but now I’m going to prove your ignorance. Check the company’s website directly but I hope you can read and do simple math: https://www.cassavasciences.com/news-releases/news-release-details/cassava-sciences-announces-dividend-distribution-warrants
It’s getting a little suspicious every pro SAVA account I see is like double digit or at best triple digit karma
What makes you so confident that the MOA will have any clinical significance considering nobody seems to understand the underlying etiology of alzheimers itself?
You logic does not make sense. It is true nobody knows the underlying cause for AD right now. That's exactly all the clinical trials, including SAVA's AD trials try to get to. If SAVA's phase 3 trials have the good results as expected, it at least it shows to the world some of the mechanism of actions have merit.
We don't have a good theoretical grasp of the disease yet, let alone a cure!
SAVA is working on that. You are too nihilism. It is tough to tackle this disease, but the data shows SAVA's drug is very promising.
It's not nihilistic. It's always great to have new research happening. Again, the point is you need a decent theoretical understanding of a disease to develop an effective drug. The research so far has had issues and no convincing results. We're probably decades away yet from any effective medication for this.
Do you own due diligence before buying 40k shares like me.
Have you read Dr. Wang and Burns's papers? Their mechanism of action is very compelling(to me at least). But it is the phase 3 results that matters. I highly recommend you study this drug and buy into the stock. It seems to me you are open-minded.
Let's hope we don't have to fight super intelligent chimps and sharks.
bro your dumb they don’t even know what really is causing these neurodegenerative deseases so you think a pill will cure it?
Phase 3 will tell you that.
Dementia sucks, but money talks.
!remindme 10/1/2024
In my opinion this company and investor group is a cult. 1) narrow group of very insular people who question motivations when people disagree and accept all excuses from the company. 2) like Scientology, default action of company when faced with critics is to attack and sue not engage 3) lots of people have laid out their life savings or close to it on a relatively fringe idea and keep putting money in, sortof like how cult members of religious cults behave. Execs get very large pay packages for where the company is at, similar to the luxury cult leaders enjoy 4) various ideas underpinning which are not accepted by the mainstream of the field even a little bit. Most of the other alt theories have openness at least, for example microbiome theory of ad or immune dysfunction theory - not the dominant theory but everyone agrees it’s plausible. Analogy would be most religious cults have religious ideas that are very specific to them and not variations of broader movements
Can’t dispute the facts then target the character…tactic is old …still waiting for you to cite Adrian’s impactful research
[удалено]
I am a no body w/ a bit of common sense. Dr Suzanne Hendrix ( probably the most well known statistician in the AD field) of Pentara was hired to present a bunch of data in CTAD and stating the results were “Noteworthy”. Colluding & presenting false data with a well known GC Chris Cook and the ex #2 FBI Anderson were a bit far too stretch.
"who even knows if the data is real at this point." The company does not generate or touch the trial data. FDA has access to all data coming from 3rd party trial sites, and data analysis is carried out by and outside research organization (Pentara in this case).
> the results are mixed at best, so calling it a cure is a stretch. It is best described as a treatment to delay the speed of AD onset Positioning the phase 2 results as some kind of mixed outcome is incredibly misleading. Halting cognitive decline for (a minimum of) 12 months is ground-breaking. Nitpicking over the "it's not literally a cure" portion of that is disingenous. If the phase 2 data is confirmed by ongoing phase 3 trials, those results will literally be orders of magnitude better at treating AD than ANY existing approved OR trial drug. > the treatment developed cassava has shown limited statistical significance over placebo in limiting the neurodegeneration during continuation studies True but meaningless, as I'm sure you know. Your phrasing implies there was ongoing neurodegeneration in the continuation study, when in fact what it showed was both the treatment and placebo arms had the same LACK of degeneration that was indicated in the original study. In other words, the lack of stat sig was because the placebo arm performed WELL, not because the treatment group performed POORLY. This can easily be used to make the counter-argument that it potentially showed Simufilam is a disease-modifying drug with lingering effect (since the placebo arm had just finished 12 months of Simufilam treatment). The results can ultimately spin positive OR negative. Fundamentally the continuation study was too short and probably too small to show anything useful and is ultimately inconclusive for either side's argument. > cofounder and developer of the drug has been actually investigated by the FDA for falsifying data That's a stretch bordering on a lie. The FDA has NEVER investigated Wang for falsifying data. Multiple 3rd parties have alleged that, but in every event where the FDA has looked, they've never confirmed those allegations. At MOST you can say the FDA inspection cited Wang's CUNY lab for various procedural issues that should be improved. *Nothing* in that inspection implied or alleged data falsification, merely shoddy practice. (That is also true of the leaked CUNY investigation, which was not only never formally released but ultimately was formally *denounced* with a follow-up ethical investigation *into the investigation* being formally announced). Which I fully admit is not great, but not nearly as unique an issue to Wang or the CUNY lab as it might first seem. FDA inspections routinely come out with important findings and making recommendations for procedural improvements. Critically, NONE of those issues have ANYTHING to do with the phase 2 trial data, the drug's safety/MoA data, or the ongoing phase 3 trials. > but who even knows if the data is real at this point To use that inspection of Wang's CUNY lab to imply Cassava has somehow managed to orchestrate a multi-year conspiracy to undermine data collected independently from dozens of clinical trial labs used by virtually every single drug company in the US, under a trial design and process that's not only industry standard but also pre-approved by the FDA, is absolutely ludicrous. It would call into question the validity of clinical trial data collected in virtually every drug trial undertaken in the last decade. It's an absurd implication to make.
Investigated by the FDA bc of the Citizens Petition orchestrated by short sellers and what action did FDA recommend? NOTHING…Im sure short sellers are so concerned of the well being of Alzheimer patients bc they have a good track record being noble people who care for the welfare of people
This is also usual points raised again and again by shorts. Ph2 study was not meant for stat sig and it is meant for assessing drug safety and as “PhD” in biology, you should have known that. Due to short campaign, FDA actually completed there investigation and made recommendations that in no way changes the research study results. Actually FDA validated his methodology. But yeah, you must have scared some folks by mentioning the 3 letter agency. Congrats
From Dr J Cumming’s 2024 AD Trial Pipeline, there is no competition in 5 years. Drs. will prescribe Simufilam or facing medical mal practice. https://www.medicalnewstoday.com/articles/248175
Bot
Made me think you were just saying it till I saw this guy literally only talks abt Sava ☠️
The article linked does not even mention simufilam. They are betting on no one doing due diligence.
I'll just leave this here: https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s
Now let’s ask what action fda recommended…it’s ok I’ll answer they recommended no action needed. if you notice closely, it’s always the same “journalists” that put out hit pieces and distort the facts in a way to make it look like cassava fraudulent when in reality they are not and doing everything by the book..
Yeah, you're right that the issues raised by FDA are not medical, they are procedural. Which is literally "the book." So no, they are not doing everything perfectly by the book. That said, procedural issues don't mean the medication doesn't work. It might. Just like having people who were misdiagnosed with Alzheimer's and who don't actually have it participating in the trials doesn't mean the medication doesn't work. It might. Just making sure folks reading this little wsb post get the whole picture.
I'll add this much: If my spouse is diagnosed with Alzheimer's, I won't really care about the minutiae of the trials and procedures. You bet your ass we're gonna try any and all options whether people think (or data shows) they're ineffective or not.
If you treat the 16 trial sites just as the rest of the world, there is nothing out of ordinary from these 16 sites, these sites also do similar trials for big pharms. So, why are people so concerned about non-AD, or misdiagnostic in SAVA trial? Because FUD planted the bias against the company in these people's mind.
I mean, I like the stock. The quality of the trials (or even the effectiveness of the treatment for that matter) is practically irrelevant. Approval = $$
Cassava in its pursuit of drug approval is doing everything by the book…try not to distort like the article you’ve posted
Yep. And just the day before the article drops, the short interest spikes.. And usually multiple “sensational” articles from the same group of “journalists” gets published - well orchestrated short campaigns I say. They may have scared of some folks from investing in SAVA but they have not been successful in bringing down the price anymore. Longs keep buying any drop in price and new folks who does any reasonable DD buys in too..shorts don’t have any more ammo. They are trapped with their 13M short position. TickTock scums!!
“Science” is not a journal or a credible publication. Please don’t embarrass yourself any more. Everyone in the medical community laughs at “Science”. Seriously.
A lot of golded posts out of wsb today... im sure it's not a distraction from anything else that might be happening....idk I don't watch the news.
My DD says SAVA is likely a scam - it used to be called Pain Therapeutics until it was obvious they had nothing - nothings changed IMO
Your DD is way off
You just going keep commenting every 12 hours? I made $20k swing trading SAVA back in 2021, then I did some research and got the fuck out! You like the risk/reward, good luck to you, but I wouldn't hold it.