(Total Views: 431)
Posted On: 04/23/2021 7:03:51 PM
Post# of 154065
Quote:
"...if the results of longhauler phase 2 are fabulous, that we could get EUA without a phase 3..."
It is my opinion that if we got 90+% efficacy on our phase 2 for LHs the US FDA still wouldn't give an EUA. The real question IMO is if we got 90+% on a phase 3 would we get an EUA; however, it would be interesting to see how far the FDA would move the goal posts. The other thing that would be interesting would be to see how fast we got numerous approvals if we were partnered with a BP.
Hey, let me know if you think I'm losing confidence in the integrity of the FDA. I would hate for that to happen.
"...if the results of longhauler phase 2 are fabulous, that we could get EUA without a phase 3..."
It is my opinion that if we got 90+% efficacy on our phase 2 for LHs the US FDA still wouldn't give an EUA. The real question IMO is if we got 90+% on a phase 3 would we get an EUA; however, it would be interesting to see how far the FDA would move the goal posts. The other thing that would be interesting would be to see how fast we got numerous approvals if we were partnered with a BP.
Hey, let me know if you think I'm losing confidence in the integrity of the FDA. I would hate for that to happen.
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