hapapapa
A lab run by a City University of New York (CUNY) scientist with ties to Cassava Sciences (NASDAQ: SAVA) and its anti-Alzheimer candidate, simufilam, were reported with a multitude of problems during a US FDA inspection in September 2022.
In that laboratory, Hoau-Yan Wang and his collaborators had evaluated blood and cerebrospinal fluid samples from individuals who had taken part in a study of simufilam.
The FDA inspection report, obtained from Science magazine, found that Wang neglected to conduct routine calibration of the equipment to ensure that the experiments were accurate. Furthermore, you neglected to complete verification experiments to ensure that the tests were accurate and precise.
Furthermore, improper statistical tests used by Wang “led to inaccurate determination of sample concentrations.”
THE Science The article also noted that CUNY initially denied inspectors access to the lab, only acquiescing two days later.
The release of the report is likely to cast further doubt on the results of the simufilam study.
In a statement provided to ScienceCassava (SAVA) said Wang’s lab is not involved in the simulfilam phase 3 program.
The company said that because the lab is engaged in exploratory research, it is not required to comply with FDA Good Laboratory Practices standards.
“The FDA inspection at CUNY did not result in any material changes to the data generated for our benefit by this academic research laboratory,” Cassava (SAVA) said.
As of 710p ET on Monday, shares are down about 1% in after-hours trading