Start a new trial while people just keep dying. Mo
Post# of 148190
COVID will be gone by the time we get approved. What’s the point of another trial if we can’t even use the drug for Covid? Good chance that Covid is a thing of the past by the end of the year. Let’s hope I’m correct, maybe not, but I wouldn’t want to bet another trial that Covid will even be a talking point by summer time.
I don’t see the logic behind any of this. The drug is extremely safe and is better than the standard of care. I realize that we had a small trial but that’s what I call absolute incompetence by both cytodyn and the FDA. Wasn’t the FDA the one to recommend a small trial ?
I can hear the FDA now “ Oh hey sorry, looks like the drugs working but we aren’t 100 percent sure.... Let’s have you guys and gals conduct another trial while people die. Maybe by the time the trial is done Covid will be over and we can delay the BLA while you guys run out of money. Sounds good ? Let’s keep pushing BP and their vaccines. Nothing to see here.
Not yelling at you but this is utter fucking nonsense to even talk about another trial. Maybe that’s why I won’t work at the FDA ever because they would fire me for calling them out on their nonsense.
Sorry but if we don’t get EAU or a phase 4 out of this I lost all faith in the FDA. It clear that we are 10 times better than the SOC and absolutely shouldn’t do another trial. Either we work or we don’t.