Revive Therapeutics Ltd (RVVTF)

[rickstereo3333]

Read the PR again....two simple words tell you all you need to know. The potential eua application based on the dsmb's advice is independent of the enrollment activity. IF the fda approves the eua the continued trial enrollment will simply bolster the case for full approval while bucil is used by patients. I totally get that ppl are frustrated and impatient but seriously. Prior to covid being used to bastardize the clinical trial process it usually took ~10 yrs and cost $500M to conduct one. Good grief!


"The Data Safety and Monitoring Board ("DSMB") are scheduled to meet this quarter to evaluate the current clinical and safety data to either make recommendations on the Study or advise on potentially halting the Study early due to positive efficacy based on other clinical outcomes evaluated such as the rate of sustained clinical resolution of symptoms of COVID-19. The Company believes that with the Omicron variant, including the BA.2 variant, being the dominate strain over the Delta variant and COVID-19 hospitalizations in the U.S. in decline, there is an urgent unmet need to treat symptom resolutions in addition to preventing hospitalizations. The Company has made efforts in determining the appropriate revised primary and secondary clinical endpoints for FDA consideration for potential Emergency Use Authorization. In parallel, the Company will continue enrollment activities in the U.S. and Turkey and is still targeting Q2-2022 to meet the enrollment goals."