Cassava Sciences Faces Renewed Scrutiny for Alzheimer's Drug Research

An examination carried out by a laboratory overseen by a scientist linked with Cassava Sciences (NASDAQ: SAVA) and their potential Alzheimer's treatment simufilam, located at City University of New York (CUNY), encountered various challenges during a US FDA inspection in September 2022. The lab, led by Hoau-Yan Wang and his team, had been studying blood and cerebrospinal fluid samples from participants involved in a simufilam trial. According to a report by Science magazine, the FDA inspection report highlighted that Wang neglected to regularly calibrate equipment to ensure the accuracy of experiments.

Furthermore, validation experiments to ensure precise testing results were not carried out. In addition, Wang's use of inappropriate statistical tests led to a "misleading determination of sample concentrations," as per the Science article. Initially, CUNY denied inspectors access to the lab, eventually granting access two days later, as noted in the report.

The publication of this report is likely to prompt further doubt regarding the results of the simufilam trial. In a statement provided to Science, Cassava (NASDAQ: SAVA) mentioned that Wang's lab is not part of the simufilam phase 3 program. The company clarified that as the lab is involved in exploratory research, it is not required to adhere to FDA Good Laboratory Practices standards.

Cassava (NASDAQ: SAVA) contested that "The FDA inspection at CUNY did not result in any significant alterations to the data generated for our benefit by this academic research lab."