BioVie (BIVI) Clinical Trial Violations Case
$BIVI stockholder filed a claim vs. BioVie, accusing them of hiding clinical trial issues.
The news about the trial caused $BIVI to fall 60%, losing $114M+ shareholder value.
On Nov 29, 2023, BioVie revealed problems in its Alzheimer's trial, including protocol violations at 15 sites.
Patients from these sites were excluded, and the issue was referred to the FDA for investigation.
During a conference call, BioVie revealed the Phase 3 trial lacked significance due to excluding some patients. This caused a more than 60% $BIVI drop.
Based on these events, $BIVI stockholder filed a claim against BioVie and its leaders:
They are accused of not sharing important information about BioVie's Phase 3 clinical trial.
The claim also suggests that BioVie didn't oversee the trial properly, worsened by COVID-19.
Considering all the representations, investors have reasons to suspect BioVie of not disclosing that the trial data was at risk, many patients had to be excluded, and the trial was expected to fail its main goals.