Clinical Trial Manager Remains Upbeat Following Bucillamine’s Latest Successful Showing With The DSMB
About a month after providing and inaugural update on Revive Therapeutics Ltd.(CNSX: RVV, OTCMKTS: RVVTF) Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19, BioMedical_trader is back by popular demand. The resident Revive expert, moderator and investor returns to the program to provide his expert take on what the latest Data Safety & Monitoring Board meeting means for the company.
To recap, Revive provided an update on its U.S. Food & Drug Administration Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine last Tuesday. To nobody’s surprise, The DSMB supported continuation of the study in its last meeting as there was no serious adverse events or safety concerns reported. There is now one final DSMB interim analysis meeting (800 patient analysis) to take place before the 1000-patient trial is complete—and that is expected to take place in Q4-2021.
As an added late wrinkle to the trial design—and supported by research under its sponsored agreement with the University of California, San Francisco in the laboratory of Dr. John Fahy regarding the utility of thiol-based drugs against the Delta variant—Revive will incorporate viral load testing to complement the study to a minimum of 300 patients.
While the market responded positively to the news, there was some confusion on whether this additional ‘benchmark’ was a positive or negative for Revive Therapeutics. Thus, we again turned to Biomedical_trader to give us his honest assessment of what this all means, and whether his prediction of above average EUA chances at the 800-patient analysis and/or 1000-patient endpoint results were still an achievable goal.
Shadd Dales: Do you think this reduces or increases the odds of receiving EUA at 800 or 1000 patients?
Biomedical_trader: So I don’t think it significantly affects the chances of getting EUA at either of those endpoints. Maybe is increases it like two percent or something because you do get a better shot at EUA if you can really fully explain how your drug is working. But it’s not absolutely necessary since we know a lot of the mechanisms in play here are coming from (the) anti-inflammatory side.
Click on the embedded link for more of our informative and fascinating interview with Biomedical_trader, in his own words.
To view our inaugural interview with Biomedical_trader, please click here.
