SAVA - Alzheimer's Drug Trial Results Questioned After 'Damning' FDA Inspection Report | Benzinga
The credibility of the clinical trial results for an experimental Alzheimer’s drug has been called into question following a critical inspection report by the Food and Drug Administration (FDA).
What Happened: The FDA report, which was released under the Freedom of Information Act, highlighted several issues with the clinical trial work conducted by pharmacologist Hoau-Yan Wang at the City University of New York (CUNY), reported Science.org.
Wang’s lab had analyzed samples of patients’ blood and cerebrospinal fluid from a key trial of the drug, simufilam, developed by his longtime collaborator, Cassava Sciences Inc (NASDAQ:SAVA).
Cassava Sciences Inc, Hoau-Yan Wang And FDA did not immediately respond to Benzinga's request for comment. (edited)
The inspectors found that Wang had not performed routine calibration of his equipment, used improper statistical tests, and failed to complete verification experiments. These issues led to an inaccurate determination of sample concentrations, raising concerns about the reliability of the trial results.
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Despite the FDA’s findings, Cassava publicly reported the trial’s findings as positive and used them to proceed ...