Unfortunately, i agree with you. I'm not expecting a response from Michael Frank but this is what i sent to him today. =================================================================== Mr. Michael Frank,
Per the latest Press Release…
“After a further in-depth review and analysis of the FDA recommendations with members of the Company’s clinical trial team, including its statistician, regulatory affairs, medical affairs, and clinical research advisors, the Company has decided that in the best interest of the Study to preserve and not compromise the integrity of the Study and keep the blinded data intact to support a potential FDA approval in the future. As such, the Company will remain with the current Study protocol’s primary endpoint of proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization.”
It would appear that the clinical trial with it’s current primary endpoint is essentially ‘dead in the water’ because the current primary endpoint is essentially outdated and it’s apparent that Revive can’t pivot to another meaningful primary endpoint that would meet the FDA’s guidelines. For someone who explicitly became a shareholder in 2020 based solely on Revive initiating this Phase III trial, it’s an understatement for me to say that i’m extremely disappointed with Revive’s management, more so when i’m looking at my unrealized +90% loss.
The best hope that shareholders have at this point is for Revive to do a deal, collaboration, or a partnership with a bigger more experienced pharmaceutical company who could then try to help salvage this trial and navigate Bucillamine through the FDA approval process.
XXXXX XXXXXXXXX Revive Therapeutics Shareholder
(By the way, do you believe the individuals who participated in Revive’s Offering months ago are just as extremely disappointed when looking at their +50% loss?) ===================================================================
Yes and the PR is a written response to the public regarding said written responses from the GDA where RVVTF said no thanks we will ignore and continue with previous end points which were already rejected by the FDA.
Hospitalizations and deaths are no longer a thing to 99%+ of the public with these weaker strains. Hence why FDA wants time to resolved symptoms.
Does this drug help people who get sick with covid get better faster yes or no? That’s it. Thats what the FDA wants to know. Not whether they will die.
The FDA is looking for essentially a stronger Dayquil for covid. Plain and simple.
Revive is ignoring that request apparently. Or the data doesn’t support it. That simple