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Posted On: 06/17/2021 3:09:36 PM
Post# of 148892
Yes it is good knowing that enrollment should be moving right from the start of the LH trial. NP did state that more people wanted to be in the phase 2 than they needed. Hopefully that number has grown since then.
My question is how many people will we have to enroll to complete a phase 3 that the FDA will actually approve with the no hoops to jump through? NP stated on a recent call that the FDA does not approve 300-400 patient trials. So doesn't that mean we should at least be over a thousand? If we do a phase 3 with ~500 patients I don't know how good I'll feel about that. . .
Any chance LH will be taken overseas for P3?
My question is how many people will we have to enroll to complete a phase 3 that the FDA will actually approve with the no hoops to jump through? NP stated on a recent call that the FDA does not approve 300-400 patient trials. So doesn't that mean we should at least be over a thousand? If we do a phase 3 with ~500 patients I don't know how good I'll feel about that. . .
Any chance LH will be taken overseas for P3?
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