CTMedic, Does there need to be a completed Phas
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Posted On: 10/20/2020 3:57:33 PM
CTMedic,
Does there need to be a completed Phase 3 trial to move on to Phase 4?
What's the case against granting a Phase 4?
I mean, the whole thing sounds very logical, and combines the positive aspects of a controlled trial with expanded access, so how do we get there?
It seems ludicrous (if true) that the p-value needed to halt the trial, and continue on to a Phase 4 would be the same. One would think that there is a lower bar to continue on than to declare victory.
Now if the bar is lower for immediate Phase 4, and we didn't hit it, then that's an entirely different conversation, but I can't believe that would be the case.
Does there need to be a completed Phase 3 trial to move on to Phase 4?
What's the case against granting a Phase 4?
I mean, the whole thing sounds very logical, and combines the positive aspects of a controlled trial with expanded access, so how do we get there?
It seems ludicrous (if true) that the p-value needed to halt the trial, and continue on to a Phase 4 would be the same. One would think that there is a lower bar to continue on than to declare victory.
Now if the bar is lower for immediate Phase 4, and we didn't hit it, then that's an entirely different conversation, but I can't believe that would be the case.
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