Case Studies
Lessons on Site Reliability & Data Integrity
Company - Biovie Pharma
Stock - BIVI
Biovie (BIVI), a biopharmaceutical company focused on developing treatments for neurological diseases, faced significant setbacks and legal scrutiny when data inconsistencies and site management issues came to light during its clinical trials. The issues primarily revolved around the lack of rigorous oversight over clinical trial sites and inadequate evaluation of principal investigators' competence. This led to questionable data reliability, undermining trial outcomes and drawing the attention of regulators and litigants.
Outcome - Numerous Class Action Lawsuits and Failed Program
Consequences of Ignoring Investor Credibility
Company - Cassava Sciences
Stock - SAVA
Cassava Sciences (SAVA), a company developing treatments for Alzheimer's disease, has been embroiled in controversy and legal challenges due to allegations of data manipulation and a lack of reliable oversight of their clinical trial sites and investigators. Accusations centered around inconsistencies and potential misconduct during clinical trials, shaking investor confidence and leading to a substantial drop in share price. The core issue: inadequate scrutiny of trial processes and the trustworthiness of their principal investigators.