Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

FDA did not reject the EUA for safety or ineffectiveness. It said the data from only 135 patients not enough to conclude anything. Rolling review ongoing. Additional data to be submitted. NIH trial could end any day upon a finding of clear superior efficacy of Aviptadil versus Remdesivir. Not clear on why such negativity. Far from over. Not just Covid but for so many other respiratory lung diseases. Either you believe it works like those whose lives it has saved, or you think they made up stories. You decide. Great time to load up even more.

~ Mathieu, Y@h00 RLFTF finance conversations

——————————————

Reply

My concern is with the FDA's approval of the Trial Plan. They upwardly revised the pln to 196 knowing full well that would be on a 2:1 treatment/placebo ratio thereby only rendering 131 "treated" (with aviptadil) patients.

Per Nrx's June 25th 2021 S-1 filing, p.75:

"The Intravenous Trial was originally conceived by us and approved by the FDA as a 28-day clinical trial."

"In December 2020, prior to unblinding, we recognized that one-third of the patients participating in the trial were still in the ICU at 28 days and notified the FDA of the need for a 60-day endpoint. The FDA amended its guidance to assess 196 participants to a primary endpoint at 60 days prior to patient-level unblinding."

"The FDA’s February 2021 guidance included a mandate to consider treatment site effects."

https://www.sec.gov/Archives/edgar/data/1719406/000119312521200558/d175615ds1.htm#tx175615_12

So instead of owning up to the error in guidance they just dumped it on Nrx & RL.

This is not the first time they did this. Look at this prior post on Reddit:

"Is a trial of 196 patients enough? Merck previously tried for an EUA for their drug due to results based off a trial with around 200 patients but the FDA decided to hold off until they received more data."

https://www.reddit.com/r/COVID19/comments/npttvu/nrx_pharmaceuticals_announces_positive_results/

~ Zorro, Y@h00 RLFTF finance conversations