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A lab run a City University of New York (CUNY) scientist with ties to Cassava Sciences (NASDAQ:SAVA) and its Alzheimer’s candidate simufilam was flagged with a multitude of issues during a September 2022 US FDA inspection.
In that lab, Hoau-Yan Wang and his associates had evaluated samples of blood and cerebrospinal fluid from individuals who had been taking part in a simufilam trial.
The FDA inspection report, obtained by Science magazine, found that Wang neglected to conduct routine calibration of equipment to make sure experiments were accurate. Also, he neglected to complete verification experiments to ensure tests were accurate and precise.
In addition, improper statistical tests used by Wang “resulted in inaccurate determination of sample concentrations.”
The Science article also noted that CUNY initially denied the inspectors access to the lab, only acquiescing two days later.
The publication of the report is likely to cast additional doubt on simufilam trial results.
In a statement provided to Science, Cassava (SAVA) stated that Wang’s lab is not involved in simulfilam’s phase 3 program.
The company said that because the lab is engaged in exploratory research, it is not required to be in compliance with FDA Good Laboratory Practices standards.
“The FDA inspection at CUNY resulted in no material change to the data generated for our benefit by this academic research lab,” Cassava (SAVA) contended.
As of 710p ET Monday, shares are down ~1% in after-hours trading
