Cassava Sciences CEO Remi Barbier on Monday shifted his defense of the company’s embattled treatment for Alzheimer’s disease: The drug is safe, he said, therefore the Food and Drug Administration shouldn’t interfere with the company’s plan to start late-stage clinical trials.
Barbier, speaking via a prerecorded video during an investor conference sponsored by the investment bank H.C. Wainwright, also backtracked from claims made by Cassava that an ongoing mid-stage study showed its drug had improved the cognition of patients with Alzheimer’s.
A citizen petition filed with the FDA last month accused Cassava of altering Western blot images and laboratory biomarker data that support its drug, called simufilam. The petition, filed by a law firm representing unnamed whistleblowers, asked the agency to halt all simufilam clinical trials and investigate the alleged data manipulation.
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