- With a decline of ~23.5%, Cassava Sciences (NASDAQ:SAVA) has extended losses into the pre-market in reaction to an after-market report that raised concerns over the quality of the studies into the company’s experimental Alzheimer’s drug simufilam.
- A letter from a lawyer named Jordan Thomas of Labaton Sucharow was posted on a government website urging Billy Dunn, the director of FDA’s center for drug evaluation and research to pause simufilam clinical trial.
- “Given the many obvious problems with the underlying research, to protect vulnerable Alzheimer’s patients, the current clinical trial should be paused while a rigorous audit of Cassava’s research is conducted,” the letter dated August 18 read.
- In response to allegations, Cassava Sciences (SAVA) said the claims mentioned in the post “are false and misleading.”
- “As a science company, we champion facts that can be evaluated and verified,” CEO Remi Barbier noted. "This helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we wish to address allegations head-on.”
In July, a Stat News report cited independent researchers who said that the Phase 2 interim results disclosed by the company for simufilam in patients with mild-to-moderate Alzheimer's were “overblown, inappropriate, and uninterpretable.”