Biotech Values

[DewDiligence]

BIVI—(-31%)—reports data-integrity issue buried in 10-Q filing:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001580149/000152013823000473/bivi-20230930_10q.htm

For example, during routine monitoring of blinded data from our Phase 3 study (NCT04669028) of NE3107, we uncovered what appears to be potential scientific misconduct and significant non-compliance with GCPs and regulation at six sites. We have alerted the FDA’s Office of Scientific Integrity (“OSI”) about these issues and believe OSI will perform a thorough, competent, objective and fair research of any potential scientific misconduct and non-compliance of GCPs and regulation. Sensitivity analysis excluding data from these six problematic sites has been performed and accounted for in the statistical analysis plan for the study (NCT04669028). Nonetheless, these findings of potential scientific misconduct and significant GCP violations may call into question the rigor, robustness and validity of the entire data set for this study (NCT04669028) and may require additional clinical studies to confirm the final results of the study.

Burying stuff like this in a long SEC filing never works. It’s better to disclose the bad news in a press release.