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Posted On: 07/19/2019 8:02:22 PM
Post# of 150148
They certainly have enough patients. I’ve seen a lot p3 hiv trials around 500. NP said the important items, no resistance or antibodies, failures switched back without issue, people lining up— one other I can’t remember right now. Though, they look to hit way above the 70% FDA request given as a goal with phase 2 feedback , I’m not sure why they need to hit a certain percentage in this case anyway. If I was on art, and there was even a 50/50 chance of this working, when failure means I just go back to my previous regimen. What is there to lose? Now maximizing how many people it works for with the overlap and density test, yes I understand. But if I was the FDA deciding, that would just be a formality with the tremendous upside, great safety numbers, and almost no downside so far.
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