It was an expected step, but a notable one nonetheless. Revive Therapeutics Ltd.(OTC:RVVTF) revealed they have submitted their Data Access Plan to the U.S. Food & Drug Administration (FDA). The maneuver is the final step required, pending FDA approval thereafter, to allow a company agent to view unblinded data of the first 210 patient data in the company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19.
Today’s news was follow-on confirmation to the May 26 press release that Revive “will submit a Data Access Plan to the FDA in early June 2022.” The company announced that following positive comments from the FDA in regards to its request to determine and agree new primary efficacy endpoints, it indeed has submitted a Data Access Plan to the FDA. The plan’s purpose is to quantify which individual or individuals related to the company can view early-study unblinded 210 patient data before deciding whether to switch primary endpoint data to a symptom focus. Currently, a reduction of hospitalizations and death are the primary endpoints for the trial.
