According to Cassava, 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 (Western blotting is a complex laboratory technique used to separate and measure proteins) in a science article published by the Journal of Neuroscience in July 2012.
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.
The Journal of Neuroscience authorized Cassava Sciences to share a statement on this matter, reprinted in full below:
“The Journal of Neuroscience follows COPE [Committee on Publication Ethics] guidelines and takes any claims of misconduct very seriously. In response to allegations of data manipulation in JNeurosci 2012;32:9773-9784 the Journal requested raw data, including images of original, uncropped Western blots. The Journal determined that there was one duplicated panel in Figure 8 and a Corrigendum was requested and will be printed. No evidence of data manipulation was found for Western blot data.”
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.”
The FDA has not engaged with the Company regarding either Citizen Petition.
About Cassava Sciences, Inc.
Cassava Sciences’ mission is to discover and develop innovations for chronic, neurodegenerative conditions. Over the past 10 years, Cassava Sciences has combined state-of-the-art technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com.
For More Information Please Contact:
Eric Schoen, Chief Financial Officer
or (512) 501-2450
Cautionary Note Regarding Forward-Looking Statements: This press release includes forward looking statements including but not limited to those regarding the conduct of a Phase 3 program with simufilam in Alzheimer’s disease, allegations and requests for actions made in Citizen Petitions submitted to the FDA, and oral or written comments made by our employees regarding simufilam and its clinical development.
Drug development involves a high degree of risk, and historically only a small number of research and development programs result in commercialization of a product.
Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the initiation, conduct or completion of our clinical studies on expected timelines, to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates, the severity and duration of health care precautions given the COVID-19 pandemic, any unanticipated impacts of the pandemic on our business operations, and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2020 and future reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release.
For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC’s website at www.sec.gov.
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No Evidence of Data Manipulation in Technical Paper Foundational to Cassava Sciences Lead Drug Candidate
Cassava Science: Journal of Neuroscience Review Shows No Evidence of Data Manipulation
Cassava Sciences (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.
From Cassava Sciences
Remi Barbier, President & CEO, Cassava Sciences, said “I’ve never doubted the integrity of our people or science. We remain focused on conducting a Phase 3 clinical program of simufilam in people with Alzheimer’s disease. It’s an important endeavor, notwithstanding pundits who may be louder than they are learned. We’ll stay the course until our job is done.”