Friday, September 25, 2020 2:58:27 PM
Aviptadil is an already approved drug .
Its been extensively studied and has real world experience with probably 1,000's of patients .
Its safety profile is well known .
Large P 3 trials are often run to try find that 1 patient that may have a very bad adverse event . For example my wife had some involvement ( in deciding not to use for the first yr ) a dialysis drug called Omonty .
Omonty ( a new drug ) had a P3 trial with 8,000 patient applications I believe ...some adverse events were noted and the Co glossed over a potentially worrisome signal .
FDA approved .
It wasn't till about the 23,000 th patient application that a patient went into shock ...and died ...while being administered the drug .
Drug was withdrawn from the market .
I dont expect a new large P 3 trial to be required for Aviptadil ...If I did I'd probably sell the stock. .
Dr Lavin ....biostats person for NeuroRx is widely respected and knows how to package the trial data they are collecting ...from all their trials ...to ensure as fast as possible FDA approval .
Kiwi ....
Ps enjoy the fishing ...for large Rainbow trout chk out my ol hood ..Nth Island New Zealand
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