Biotech Values

[jbog]

The Securities and Exchange Commission or SEC, announced Cassava Sciences its founder and former CEO, Remi Barbier, and its former Senior Vice President of Neuroscience, Dr. Lindsay Burns, will pay more than $40M to settle charges related to misleading statements made in September 2020 about the results of a Phase 2 clinical trial for the company's purported therapeutic for the treatment of Alzheimer's disease...According to the SEC's order, Wang received information that unblinded him to some aspects of the Phase 2 clinical data, which he used to identify about a third of the patients enrolled in the trial. In a blinded clinical trial, to avoid bias in the results, no one involved in the trial knows the treatment assignment of individual patients, including whether the patient received a placebo or an active dose of the therapeutic. Using information that unblinded him to aspects of the trial data, Wang was able to manipulate the data to create the appearance that the drug had caused dramatic improvements in biomarkers associated with Alzheimer's disease, such as total tau and phosphorylated tau, which are common indicators of neurodegeneration in Alzheimer's patients. The order also finds that Wang knew Cassava would disclose the manipulated data when announcing the results of its Phase 2 clinical trial, and Cassava did in fact publicize the data in a press release and investor deck issued on September 14, 2020. The SEC's related civil complaint alleges that Cassava and Burns misled investors with claims that the Phase 2 trial was conducted in blinded conditions, even though Wang had been unblinded.

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https://thefly.com/n.php?id=3989496