An excerpt from a long report and recommendation released Wednesday by Magistrate Judge Ona Wang (S.D.N.Y.) in Cassava Sciences, Inc. v. Bredt; for more details, read the whole opinion:
At various dates in 2021, the Neuroscientist Defendants filed a Citizen Petition and sent publicly available letters to the Food and Drug Administration ("FDA") expressing "grave concerns about the quality and integrity of the laboratory-based studies surrounding" simufilam {a [Cassava-developed] drug intended to treat Alzheimer's disease} and claims about its efficacy. The Neuroscientist Defendants accuse Drs. Burns {Cassava's Vice President of Neuroscience} and Wang {Associate Medical Professor at the City University of New York … and Cassava's "academic collaborator"} (and others) of intentional data manipulation and misrepresentation in Cassava's preclinical and clinical studies, and request that the FDA halt the ongoing trials of simufilam pending an audit of these issues….
The inference the Neuroscientist Defendants draw after examining the data and empirical research is not that "Cassava is a fraud" or even that "simufilam is not effective," which would have been analogous to the statements [given as examples in a past Second Circuit precedent -EV]. Rather, the Neuroscientist Defendants drew a more measured and nuanced series of inferences from Cassava's own underlying research, on which Cassava relies to support clinical testing of simufilam in humans: namely, that the research may be unreliable, based on certain irregularities in the reporting of data in the research.
Numerous press releases and basic science papers are attached and incorporated into the [Complaint], as if all of these statements, taken together, could be sufficient to "prove" Cassava's scientific conclusions to be true (or not). This is part of the "ongoing discourse" referenced in [the precedent] that courts should avoid. Indeed, the parties' repeated filings concerning CUNY's subsequent investigation (and its results) are irrelevant to this analysis. Rather, the fact of the investigation, conducted well after the Neuroscientist Defendants raised their concerns, shows that these statements are also not yet verifiable.
