Wednesday, December 20, 2023 9:25:24 PM
I mean really, when I show you trial data and link peer reviews in support of what management has accomplished, and demonstrate how the ACTIV-5 data was skewed, you come back with some barb about me drinking KoolAide?
There's no excuse for looking at the data, and not concluding that the FDA should have awarded us an EUA. That negligence is permitting the preventable loss of life. Are you seriously condemning management, and defending the FDA?
The trial size was determined with management and the FDA. Compare that trial size to the initial design of ACTIV-5.
"Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform..."
https://clinicaltrials.gov/study/NCT04583969?intr=lenzilumab&rank=2
Or look at the plan for LIVE-AIR.
"Approximately 516 patients will be randomized to receive lenzilumab + SOC vs. placebo + SOC in a 1:1 ratio."
https://clinicaltrials.gov/study/NCT04351152?intr=lenzilumab&rank=3
If our trial size was too small to qualify, then doesn't that also mean that the ACTIV-5 trial was too small to disqualify? Yes, I know they bumped up the population, but not beyond our trial population.
And what about sabizabulin?
"A total of 204 patients were randomly assigned to treatment..."
https://evidence.nejm.org/doi/full/10.1056/EVIDoa2200145
Of course, Veru claimed that, "The mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo." Ridiculous.
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