According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose that:
- the ongoing COVID-19 pandemic caused “limited access” to clinical trial sites, significantly affecting BioVie’s ability to conduct proper oversight of the clinical trial;
- due to the “limited access” to the clinical trial sites, the trial was at higher risk of having “significant deviation from protocol and Good Clinical Practice (GCP) violations” and “anomalous data;”
- BioVie was experiencing issues with the contact research organizations it had retained, creating greater risk of the trial being in non-compliance with GCPs;
- BioVie had identified “higher than expected levels of deviations” in the data;
- due to a “highly unusual level of suspected improprieties” there was a heightened risk a majority of the clinical trial subjects would be excluded;
- as a result of the exclusions, there was a heightened material risk that the clinical trial would “not achieve statistical significance;” and
- as a result of the foregoing, statements about BioVie’s business, operations, prospects, and/or compliance with GCP were materially false and/or misleading and/or lacked a reasonable basis at all relevant times.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
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