-=Cassava Sciences (SAVA) : Journal finds no proof of tampered Alzheimer's data

• Co has been informed by the Journal of Neuroscience that it determined that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease.  
• Allegations of data manipulation caused SAVA stock to plummet in August. One of the claims was that Cassava altered test images called Western blots. The Journal of Neuroscience says there's no evidence to indicate Cassava tampered with those images in a July 2012 paper. That paper was foundational to the company's experimental Alzheimer's drug, simufilam.
• "I've never doubted the integrity of our people or science," Chief Executive Remi Barbier said in a written statement. "We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer's disease."

Cassava Sciences: Review of company's article published July 2012 describing a new approach to treating Alzheimer's disease finds no data manipulation

• SAVA has been informed by the Journal of Neuroscience that there is no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease. The peer-reviewed article was co-authored by scientists and academic collaborators for Cassava Sciences and is foundational to simufilam, the Company's lead drug candidate for the proposed treatment of Alzheimer's disease.
• In August 2021, a law firm representing anonymous short sellers submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) that alleges, among other things, data manipulation in Western blots in a science article published by the Journal of Neuroscience in July 2012. (Western blotting is a complex laboratory technique used to separate and measure proteins). In response to this and similar on-line allegations, the Journal of Neuroscience requested raw data for the article, including images of original, uncropped Western blots. Having received that data and completed its review, the Journal of Neuroscience states: "No evidence of data manipulation was found for Western blot data." One human error that does not impact data conclusions was identified (a duplicated panel in Figure 8B of the article), and the publisher is expected to print a correction.
• In October 2021, a second Citizen Petition was submitted to FDA by an individual unknown to Cassava Sciences. This second petitioner "is requesting the FDA for approval of simufilam and immediate initiation of Phase 4 trials for further efficacy, safety assessment and, most critically, to address one of the greatest needs in modern medicine."
• FDA has not engaged with the Company regarding either Citizen Petition.

Cassava began enrolling patients in a Phase 3 study of its drug, simufilam, in early October. The news followed a positive 12-month study in which patients' cognition improved by 3.2 points on a 70-point scale. Most patients show declines. Even Biogen's (BIIB) approved Alzheimer's drug, Aduhelm, only slows the cognitive decline in mild-to-moderate Alzheimer's patients.

Critics of SAVA stock note the study was open-label. That means patients knew they were receiving the experimental drug. The Phase 3 study, however, will test simufilam against a placebo.