SAVA: FDA Response to Short Seller Citizen's Petition Expected Soon

While the SAVA put play has already been covered here, I figured I would cover the bull case in the event SAVA turns out not to be fraudulent.

On August 23, 2021 a Citizen’s Petition submitted by lawyer Labaton Sucharow (on the behalf of short sellers) was submitted which sought to halt the Phase 3 trials of Cassava Science’s flagship drug Simufilam which seeks to increase the cognition on those suffering with mild-to-moderate Alzheimer’s disease. The petition has many claims, the foundation of which is Cassava manipulated the data which showed their drug’s efficacy in order to drive the share price up for executives to cash out on a stock price driven payment plan. The above link goes over the other accusations in more detail.

Since then, the Journal of Neuroscience has vouched for the data related to Western Blots stating there appears to be no manipulation. However, a few months later the JoN published two Expressions of Concern which acknowledge the concerns about the biomarker data and cite an ongoing investigation conducted by The City University of New York (CUNY). The university is currently investigating the data manipulation accusations against a Dr. Wang, an associate medical professor at CUNY. This is significant as Dr. Wang is the one who handled the Western Blots and is the author of the paper which serves as the backbone to Simufilam’s efficacy. The JoN stated in the Expression of Concern that they were aware of the CUNY investigation and will wait to hear from them before redacting or pressing forward with their concerns.

On December 21, 2021 an independent journal known as Neuroscience reviewed other Western Blot data covered by Dr. Wang in a 2005 paper for Cassava, then known as Pain Therapeutics, in which Cassava sought to bring an opioid alternative to the market. Upon reviewing the data, Neuroscience found no evidence of manipulation. This is significant as this is one of the pieces of contention cited in the Citizen’s Petition which seeks to undermine Dr. Wang’s credibility.

Given the Citizen’s Petition was submitted on August 23rd, the FDA has either 150 or 180 days (date is debated) to respond to the Citizen’s Petition. This either lands on January 20th or February 19th, depending on which date above is accurate. If the FDA declines the Citizen’s Petition and allows Cassava to proceed with their Phase 3 trials there will be significant upward movement in share price. If the FDA acknowledges the Citizen’s Petition, the share price will plummet over time down to around $7 per share (cash value), assuming Cassava does not recover.

Given the controversy around Aduhelm, Biogen’s Alzheimer’s drug approved by the FDA with much debate due to safety concerns, the FDA is clearly desperate for a treatment for Alzheimer’s disease. If Cassava is legit, the company will take a major market share in the Alzheimer’s realm and reach an insane valuation. Recently Biogen announced they were cutting the price of Aduhelm treatment in half to become more competitive in the market amidst concerns of safety and price of treatment.

The above serves as a crude representation of the controversy surrounding Cassava Science and does not go into extreme detail of every accusation. I encourage everyone to do their own research before committing to a position either way. This is extremely volatile, it’s going to the moon or in the dirt. Please proceed with caution.

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As the one who wrote the DD on the potential puts play on SAVA, I want to say that this is very well done and I agree with many of the statements made here. Excellent job!

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Good movement today, some fake DoJ letter circulating claiming to investigate the short sellers behind SAVA’s decline. Positive news of another institute investing in SAVA came out today.

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I know nothing about pharma but saw this post on WSB:

Basically it’s saying the FDA has to respond to the short sellers petition by 2/21. Not sure how much validity there is to it though.

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The point is valid as far as the timeline goes, there’s debate whether it’s 150 or 180 days. My position is based on the 180 day mark as I won’t get burned if 150 isn’t the case.

Upon further research I’ve grown a bit more cautious as to my previous understanding I thought this was purely a binary event: they either acknowledge or decline the CP. I found that the FDA can also defer the CP, which states they need more time to adjudicate the matter. If playing shares, no biggie. If you’re playing Jan calls for the 150 mark, this is a death sentence. Same goes for 180 if that’s the timeframe the FDA responds closest to.

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! IMPORTANT !

According to some discord users, they claimed to have contacted the FDA Docket Management division and were told the expected response date is 2/22/22. Could respond earlier than that though.

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Here’s a link to a Dr. Baker (doctor for two individuals enrolled in the P2 trials) describing some of their improvements..

Say what you want about the channel or Joe Springer as I’m not the biggest fan of the way he presents things but listening to Dr. Baker speak on the noticeable improvements in his patients without any adverse effects was very encouraging to me.

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Getting bad vibes from this in retrospect. Dr. Wang had another article where his images were problematic, seemingly copy pasted. His fellow authors on the 2021 paper had no explanation and redacted their article and look to resubmit it without his contribution.

I think Dr. Wang is extremely sketchy and given his lab was the only lab to show SAVA’s efficacy this is starting to stink a bit. I sold my entire position earlier this week and will likely remain on the sidelines going forward.

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