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# ‘Damning Report’ on Alzheimer Drug Tests: Article
- URL: https://www.fdaweb.com/damning-report-on-alzheimer-drug-tests-article/
- Published: 2024-03-14T12:00:00.000Z
- Updated: 2026-09-14T14:25:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156561

A *Science* report supported by the Science Fund for Investigative Reporting details FDA’s concerns about the results of tests conducted in a City University of New York (CUNY) laboratory run by pharmacologist **Hoau-Yan Wang** on Cassava Sciences’ potential Alzheimer’s drug simufilam. The article [says](https://www.science.org/content/article/damning-fda-inspection-report-undermines-positive-trial-results-possible-alzheimer-s?ref=fdaweb.com) (includes a link to the FDA Establishment Inspection Report (EIR)) agency investigators found that Wang never performed routine calibration of his equipment or completed verification experiments to ensure his tests were accurate, sensitive, and conducted with appropriate precision. They also said he used improper statistical tests that resulted in inaccurate determinations of sample concentrations.

University of Southern California neuroscientist **Len Schneider**, who reviewed the FDA report at the request of the magazine, said, “Essentially, FDA said ‘You can’t trust any of this.’” But, *Science* reports, Cassava used the results as evidence of their drug’s efficacy. The company publicly reported the trial’s finding as positive and the results helped secure approval for the Phase 3 trials that are now underway, it says.

The article says FDA, CUNY, and Wang all declined to comment on the agency EIR.

*Science* says it is unclear why FDA waited two years to investigate how Wang handled the samples or why it only looked at the simufilam study, given that Wang tested samples for other Cassava studies. “Whatever the reason,” it says, “the inspectors found concerns that went beyond poor laboratory practice. A key problem, they wrote, involved how Wang handled ‘outlier’ data.” The story reports Wang agreed he had made errors and rechecked the rest of the data, finding no new anomalies. But the inspectors said their review of the same spreadsheets identified several additional examples affected by similar errors. They said Wang agreed with their findings.

FDA declined to say whether the EIR would affect its review of the Phase 3 trials. Schneider told *Science* the FDA report showed that nothing can be concluded from the tests run in Wang’s lab. It is a “damning report,” he said.