Here is the results. NONE or if you think it is over. What about the other investigation? I have not seen any results yet and we may never hear the results as that is a possibility..
This is from the SEC the security exchange commission which investigates securities fraud.
The SEC Recommends Closing Cassava Sciences Investigation
Cassava Sciences is working on an Alzheimer's Disease (AD) small molecule drug called Simufilam, currently in phase 3 trials. Over 99% of AD therapies attempted have failed, which is why the company has chosen to take a novel approach.
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Simufilam is a pill with no known safety issues after over a quarter of a million doses. Many other AD therapies are full of safety issues, such as Aduhelm from Biogen (BIIB), a good face of the amyloid theory drugs, that had a major problem with brain swelling and bleeds. Further, Simufilam is a pill compared to competitors who have chosen to pursue an IV injection method, such as Aduhelm. A pill is cheaper, safer, and more manageable. If Simufilam and an IV method are approved with the same benefit, the pill would far outperform the IV in sales.
While this drug and theory on AD is new to many investors and is still unknown by many scientists, it has actually been in development for over 15 years. Below is the company's slide on the development history.
Simufilam developmental history
Corporate Presentation
Method of Action
Simufilam had a dual method of action from binding to a single target. The result of this is the reduction of neurodegeneration and neuroinflammation. The traditional approach for years has been around the Amyloid theory, which:
"suggests that the deposition of Amyloid β (Aβ) in the brain triggers a chain of events, involving the deposition of phosphorylated Tau and other misfolded proteins, leading to neurodegeneration via neuroinflammation, oxidative stress, and neurovascular factors."
Cassava Sciences' theory is around Altered Filamin A (FLNA). What differentiates Cassava Sciences is that it is an entirely new theory on what causes AD. Below is the company's corporate slide on the method of action.
Method of Action Simufilam
Corporate Presentation
Clinical Data
AD is a disease of continual decline. A successful drug would noticeably slow the decline. An incredible drug could stop the decline. A Nobel prize-winning drug could reverse cognitive decline. Dr. Robert Howard, a professor of old age psychiatry and an expert in clinical trial design at University College London, said, "Generally, in this area, we would regard slowing or stopping of cognitive decline as a win."
Simufilam has reversed cognitive decline in 100 patients in an open-label trial at 12 months. Previously, the longest cognitive decline that has been reversed was six months. Below is the highlight of that trial.
12 month
Corporate Presentation
To show how drastic Cassava Sciences results are compared to other AD drugs, I have a graphic comparing them. In the chart are the clinical results of Biogen's Aduhelm, which received accelerated approval, Eisai's Lecanemab, which received breakthrough drug designation, Eli Lilly's (LLY) Donanemab, which received breakthrough drug designation, placebo averaged from multiple drug trials, and Roche's (OTCQX:RHHBY) Gantenerumab, which received breakthrough drug designation. Check out the graphic below.
comparison
Created
SEC Clearance
As seen below, the SEC has officially closed its case. The below document was obtained through a FOIA request. I have highlighted crucial wording.
SEC Cassava Sciences
SEC
EDIT 9/23/2022 by Jacob Braun
The company has since stated that they have never received a "termination letter," so early clearance reporting was false. However, the above document still appears valid. Changes to the headline have been made to reflect that the SEC has recommended a case closing instead of a clearance.
discl
Cassava Sciences
1. Cassava Sciences has stated that it intends to release 12-month data for 200 patients (100 patients have already been released) from its open-label extension trial.
2. In addition to 200 patient data, the company plans to release the biomarker data for 25 patients in that trial.
3. Recently, the company stated that results from its blood-based diagnostic test SavaDX should be released sometime between now and the first half of 2023. SavaDX could be worth over a billion dollars, but the company has put it on the back burner as it focuses on the real prize in Simufilam.
4. In mid-2023, the company will release data from its cognitive maintenance study. In this study, patients who have been on the drug open-label for 12 months will be randomly split into placebo and drug group trial arms for six months. This trial will give out placebo-controlled, drug withdrawal, and 18-month open-label data. All three of these pieces of data will give a much better picture to investors and could potentially propel the company to some elevated regulatory status considering that the company only added the CMS trial after meeting with the FDA in 2021.
cms
Corporate Presentation
5. Finally, we can expect phase 3 trial results in mid-2024 from both of the company's phase 3 trials. This is the data that will get the drug approved or denied and is the most critical event for the company.
phase three
Corporate Presentation
source
https://seekingalpha.com/article/454233 ... estigation