I'm an MD with training in epidemiology and biostatistics. I have said before on this board that this idea that CYDY investors know Leron works so the FDA should approve it, has been silly. Writing letters to senators, signing petitions to the White House, alerting media--- the answer to all of that has been that it has to be proven by prospective controlled trials before any of that is credible.
This report of the m/m trial changes the whole landscape dramatically. The statistically significant results of the NEWS2 endpoint is reasonable scientific proof that Leronlimab changes the course of COVID-19. It reasonably admits the scientific conclusion that Leronlimab decreases the morbidity and ultimately the mortality of COVID-19.
There is an ongoing discussion in the world of statistics about the use of p-value (frequentist statistics) as criterion of proof. It's a very subtle topic. For just one example, the usual cut off of 0.05 as the level required for significance is really just an arbitrary consensus. It makes sense in that we need uniform standards in medical research, but it's not an immutable criteria of truth; it's simply a judgment call on the chance that a clinical difference is an artifact of the random distribution of the mean of the treatment group to the mean of the placebo group as expressed in the standard deviation. IMO, the evidence is now reasonably actionable that a safe drug like Leronlimab should be approved for use in COVID-19.
Now is the time when people should demand that the FDA put aside bureaucratic rigid adherence to technical details of protocol (or subtle influences of Big Pharma) and approve Leronlimab.