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Posted On: 07/14/2020 7:45:54 AM
Post# of 72440
"I think we may even see a tweak in what the phase design will be. Like possibly a P2/2b,..."
It is not frequent but not unknown for the FDA to accept two P2 trials with outstanding results as the basis for an NDA. If Brilacidin is classified as an NME then the precedent for 2 P2 trials may not be as strong.
Awaiting more data here, also.
It is not frequent but not unknown for the FDA to accept two P2 trials with outstanding results as the basis for an NDA. If Brilacidin is classified as an NME then the precedent for 2 P2 trials may not be as strong.
Awaiting more data here, also.
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