It states, “No evidence of data manipulation was found for Western blot data.”
AUSTIN, Texas, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: 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 disease1. 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.
“I’ve never doubted the integrity of our people or science,” said Remi Barbier, President & CEO. “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.”
In August 2021, a law firm2 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.
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.”
FDA has not engaged with the Company regarding either Citizen Petition. |
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