Earlier this week, Cassava Sciences defended itself against allegations regarding the validity of trial data submitted to the FDA, but now it seems a key part of Cassava's defense — the independent company it claims generated its data — is denying involvement.
After a citizen's petition along with a "whistleblower submission" letter to the FDA was posted on a U.S. government website requesting the FDA halt the current clinical studies of Cassava's simufilam, the company fired back with a Q&A-style press release refuting the allegations point by point. But one point in particular is causing an issue:
Fiction: Biomarker data is generated by Cassava Sciences or its science collaborators and therefore are falsified.
Fact: Cassava Sciences’ plasma p-tau data from Alzheimer’s patients was generated by Quanterix Corp., an independent company, and presented at the recent Alzheimer’s Association International Conference
Massachusetts-based Quanterix released a brief statement this morning saying that while Cassava had previously used Quanterix’s lab for sample testing, "Quanterix or its employees did not interpret the test results or prepare the data charts presented by Cassava at the Alzheimer’s Association International Conference in July 2021 or otherwise."
The law firm involved in the citizen's petition, Labaton Sucharow, also posted a rebuttal press release, pointing out that, "Since the issuance of the press release, leading international experts on scientific integrity have independently validated key aspects of the Citizen Petition and have posted comments on PubPeer. On Twitter, they have critically questioned the company's response."
The press release, however, also noted that the petition was filed on behalf of Labaton Sucharow clients who "collectively have expertise in neuroscience, drug discovery, biochemistry, and finance" — but also hold short positions in Cassava stock.
