The outlook for Revive Therapeutics Ltd. (OTC:RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine to treat COVID-19 got a little brighter on Thursday. The U.S Food and Drug Administration appears to be amenable to the company’s submitted request to change the trial’s primary endpoints to a ‘symptoms’ focus, as announced on May 16. Although the FDA did not officially grant primary endpoint change yet, Thursday’s news was enough to catalyze forward-looking investors into action, sending Revive shares higher in the U.S. by +21.06% on the best volume in six weeks.
Revive Therapeutics reported that pursuant to its submitted request to change the trial’s primary endpoints to a ‘symptoms’ focus, it has received “positive comments” from the FDA in regards to its request to amend new primary efficacy endpoints for the current trial. This includes the rate of sustained clinical resolution of symptoms of COVID-19, which addresses the shift in clinical outcome. The positive comments following Revive’s May 16 submission are a constructive sign that the FDA is an ally in the endpoint change process.
