Revive Therapeutics Ltd (RVVTF)

[bostrom]

THE FDA Recommended TO PROCEED April 23rd for phase 3 WOW

7 MONTHS AGO

Revive Therapeutics Announces U.S. FDA Recommendation to Proceed Directly Into A Phase 3 Confirmatory Clinical Trial




https://www.globenewswire.com/news-release/2020/04/23/2020948/0/en/Revive-Therapeutics-Announces-U-S-FDA-Recommendation-to-Proceed-Directly-Into-A-Phase-3-Confirmatory-Clinical-Trial.html


In addition to its recommendation, the FDA provided valuable guidance on study design and outcome measures for the Phase 3 study. Importantly, the FDA agreed that Revive could rely on its data included in its previous IND with Bucillamine for gout to support the COVID-19 Phase 3 study and, therefore, the Company did not have to perform any Phase 1 or Phase 2 clinical studies. The Company, along with its Contract Research Organization, Pharm-Olam, LLC, and its clinical development team led by Dr. Kelly McKee, Jr., MD, MPH, Chief Scientific Officer consultant and Dr. Onesmo Mpanju, PhD, Regulatory Affairs consultant, are actively incorporating the pre-IND meeting guidance and preparing the package for submission to the FDA. The Company expects to file the final IND within the next 60 days and will plan to initiate the Phase 3 study thereafter.