Replies to post #33296 on Revive Therapeutics Ltd (RVVTF)

[Ecomike]

There is meat sandwich #2 friends and fiends

"Regardless of the outcome, the Company would proceed to seek a meeting with the FDA to agree on a proposed plan for potential regulatory approval."

and a side dish of details:

Further to the Company’s recent submission of the Study’s amended protocol, the Company has been in communication with the FDA to submit a revised protocol with a new primary efficacy endpoint, specifically, assessing the difference in the proportion of participants with at least two clinical improvements in symptoms of COVID-19 at Day 14 compared with baseline between Bucillamine versus placebo. Additional secondary endpoints may include clinical outcome (death or hospitalization), the time to the polymerase chain reaction resolution, disease severity, supplemental oxygen use, and progression of COVID-19. The Company expects to submit the revised protocol next week.

Should the FDA agree with the revised protocol, the Data Safety Monitoring Board (“DSMB”) will review the completed Post-Dose selection data of approximately 500 subjects in the context of the new primary endpoint.