Revive Therapeutics Ltd. (OTC:RVVTF) moved closer towards potential endpoint change in their Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19. The FDA officially approved the company’s Data Access Plan (DAP) to allow for the unblinding of the pre-dose selection data to a designated company statistician. This marks the final regulatory hurdle between Revive reviewing data and determining whether to pivot to revised trail endpoints.
The news was announced after market open on Friday, in what has become a recent deviation from customary pre-market morning releases. In it, Revive Therapeutics disclosed that with DAP approval in-hand, it will now proceed to unblind the pre-dose selection data to potentially support the amended study protocol with the new primary efficacy endpoints. This will involve reviewing data from the first 210 patients and determining whether targeting symptom reduction gives the trial the best chance to succeed.
