Cassava (SAVA) is heading for the moon after FDA dismisses the ill-regarded Citizen’s Petition

First off, thanks to u/Internal_Ad_1091 for bringing my attention to this stock.

I am not yet a physician like u/Internal_Ad_1091, but I am a soon-to-be double doctor (MD/PhD student) giving my two cents on this stock.

Recap: Cassava sciences was attacked by Dr. David Bredt who filed a citizen’s petition to the FDA claiming that Cassava had committed fraudulent science, therefore requiring that it halt all trials. That is why the stock is down from its high of ~$140. Yes, there is also Dr. Geoffrey Pitt who filed the claim with him, but he is not really important here.

What is important to know is that there are so many possible conflict of interest tied to Dr. David Bredt that we need to know about and WHY HE WANTS TO SEE CASSAVA FAIL. I am planning on submitting a tip to the SEC that can hopefully lead to a formal investigation on Dr. Bredt.

  1. He previously worked as Vice President of Integrative biology at Eli Lilly from 2004 to 2011. And Eli Lilly currently is seeking expedited approval for its own Alzheimer’s therapy called donanemab that is directly competing with Cassava. Donaemab is not looking too good right now because it acts similarly to Biogen’s approved Aduhelm which causes brain hemorrhages in 40% of patients. Look, Dr. Bredt did his PhD under Dr. Synder, a world famous Neuroscientist. And it is very likely that his work at Eli Lilly pertained to the development of drugs revolving around his expertise – the brain. Given that a drug development cycle lasts decades and the phase 1 trial of the drug started in May of 2013, it is VERY LIKELY that Dr. Bredt was at Eli Lilly (2004-2011) when the development of donanemab came about. And it is VERY LIKELY he led the majority of that development as the VP. Though the incentive structure varies by company, it is also VERY LIKELY that Dr. Bredt wins big when donanemab wins big.
  1. Dr. Bredt is now working at a private equity firm called MPM capital which recently announced that it was funding Protego, a startup developing a therapy that TARGETS PROTEIN MISFOLDING to treat Alzheimer’s disease. This is in direct competition with Cassava’s Simufilam which tries to TARGET FILAMIN A PROTEIN MISFOLDING. Dr. Bredt said in his interview with The New Yorker that after reading Cassava’s papers, he thought that Cassava was “making statements that were incompatible with biology and with pharmacology.” HELLO? The company you advise poured at least $10mil into Protego that literally tries to replicate Cassava. And the timing is also very convenient. MPM Capital invested in Protego in July 2021 and Dr. Bredt submitted the Citizen’s petition a month later. The only angle I see: Dr. Bredt is actively trying to slow down Cassava to buy more time for Eli Lilly, MPM Capital, and Protego. And his integrity and impartiality are compromised due to the conflict of interest from his previous and current employment.
  1. Another suspicious note about Dr. Bredt is that he NO LONGER HOLDS SHORT POSITIONS ON SAVA. Wait, hold up. I thought he firmly believed Cassava conducted fraudulent science that deserved to be stopped? If he was so confident that the FDA is going to halt the trials, thus leading to the downfall of Cassava, why is he out? Does he know that the FDA is going to dismiss his weak allegations which will decimate his short positions? I don’t know, but it’s not looking too good for Dr. Bredt.
Cassava (SAVA) is heading for the moon after FDA dismisses the ill-regarded Citizen’s Petition

From The New Yorker Article (https://www.newyorker.com/magazine/2022/01/24/jordan-thomas-army-of-whistle-blowers)

Speaking of weak allegations, let’s look at what Dr. Bredt claims in his citizen’s petition to the FDA. I won’t go too much in depth here, but let’s see how his claims stack up.

  1. Biomarker Data:

Dr. Bredt insinuates that Cassava forged the biomarker data by re-doing the bioassay themselves which was initially outsourced to an external lab. The external lab found the bioassay to show no therapeautic implications. Although this article does well explaining it, I will quickly recap: The external lab that Cassava outsourced to had no experience working with this protocol, thus giving weird data for patient AND control bioassays. What this means is that the external lab seriously messed up somewhere in the procedure and yielded false data. This was honestly a bad decision on Cassava’s end for not making sure the external lab had the right expertise to conduct this study, but this doesn’t mean Cassava forged the data.

Dr. Bredt also claims that figure 4 in a POSTER presentation is missing ONE patient data. Look, in academic research, poster presentations are considered a trial-run to see people’s reactions before going ahead and publishing a paper. It’s not a high stake ordeal. Case in point – I did a poster presentation at a conference as a sophomore in college. Instead the peer review paper you publish IS the real deal. When you analyze hundreds of clinical data, it is likely that you make a small error making those graphs. And especially for a low stake game like a poster? Very likely. Not including ONE patient data out of hundreds is not going to convince the FDA to stop trials.

2) Integrity of Western blots

Don’t really have to explain a lot here. Dr. Bredt claimed data manipulation of western blot data from three papers.

  1. 2005 Neuroscience Journal paper (Dr. Bredt’s claim DEBUNKED by ethics committee at Neuroscience.)
  2. 2012 The Journal of Neuroscience paper (Also DEBUNKED by the journal)
  3. 2008 PLoS ONE journal – also most likely going to get debunked based on the outlandish claims of the previous two

3) Use of dead Human Brain tissue

Dr. Bredt does make good points about using dead brain tissue and attacks it. Yes, using a dead human brain is not the best method to use, but in a world where we cannot cut open living human skulls, this is the best option we’ve got to see the therapeautic workings in a human model. Also, the study that Dr. Bredt attacks is not a foundation study to Cassava Sciences. It is only there to check off boxes to show the FDA that they did an ex vivo (outside the living body) study to show efficacy of their treatment.

I seriously doubt the FDA not dismissing this citizen’s petition and the stock will bounce back to its normal level ~$150 when they dismiss the allegations. So for those doubting SAVA and thinking about selling the stock, I urge you to hold.

TL;DR: Dr. Bredt has numerous conflict of interest where he benefits from the demise of Cassava Sciences. Dr. Bredt’s claims on SAVA does not stack up very well and the stocks will bounce when FDA dismisses the case in February.

This article was written by u/quarter-in.