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Re: JoeBenson post# 36245

Monday, 09/18/2023 4:48:59 PM

Monday, September 18, 2023 4:48:59 PM

Post# of 36577
I'm looking forward to this year's Annual Shareholders Meeting.
Refresher...

Here's a few emails i sent to Michael Frank back on March 30th of this year, and his replies.
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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trial with it’s current primary endpoint is essentially ‘dead in the water’, not only because the current endpoint is outdated but also because it’s apparent that Revive can’t pivot to another meaningful primary endpoint that would meet the FDA’s guidelines because such data was not collected. 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.
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. Looking at the best interests of shareholders, what is Revive's plan moving forward?

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?)

Michael Frank's reply...

XXXXX,
Revive’s management ?
Go speak and argue with the fda
Atea , apli, cytodan , humanigen etc all had difficulty getting through the FDA.
FDA is the governing body
Shareholders knew the risks here with the FDA
Regards
Michael Frank
CEO
Revive Therapeutics Inc.
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My follow up email...

Mr. Michael Frank,
Per the latest Press Release

Although the Study was originally designed for a ‘hospitalization or death’ primary endpoint, and it completed enrollment of almost three-quarters of the Study’s recruitment goal and recorded specific clinical symptoms (i.e. cough, fever, heart rate, and oxygen saturation), the Study was not designed to take into account all of the symptom assessments and supporting data outlined in the FDA guidelines to warrant a primary symptom-based endpoint for COVID-19 studies.

A poorly designed clinical trial is not the FDA’s fault, the fault falls on Revive’s management.

XXXXX XXXXXXXXX
Revive Therapeutics Shareholder



His reply...

the trial was designed for hospitalization not symptoms that’s why more difficult
hospitalization environment changed

Michael Frank
CEO
Revive Therapeutics Inc.
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