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Posted On: 07/15/2020 1:01:57 AM
Post# of 151838
Why indeed is the FDA requesting additional monotherapy patient data.
That is the question.
I think the best answer is that the FDA is nervous about approving a higher dose than what was tested in phase 3.
This is most likely answer if the FDA has never done this before.
That is the question.
I think the best answer is that the FDA is nervous about approving a higher dose than what was tested in phase 3.
This is most likely answer if the FDA has never done this before.
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