Small biotech BIVI joins the "screwed by the CRO"

Small biotech BIVI joins the "screwed by the CRO" club. It appears that protocols were not followed at 15 of 37 clinical trial sites, so they only have good data from a small subset -- 47 patients, for whom it seemed to work somewhat against Alzheimer's.

Needless to say, their stock went down hugely.

Quote:

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Sponsor Identified Issues Relating to Significant GCP Violations and Protocol Deviations, Which Allowed for Data from Only a Subset of Enrolled Patients to be Included in the Efficacy Analysis; Sites Suspected of Improprieties Have Been Referred to FDA

.... This highly unusual level of suspected improprieties led the Company to exclude all patients from these sites and to refer them to the U.S. Food and Drug Administration (FDA) Office of Scientific Investigations (OSI) for further action.
https://finance.yahoo.com/news/biovie-announc...00826.html

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