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Posted On: 03/10/2021 3:20:40 PM
Post# of 148936
“Do you see the dichotomy in those two statements?”
Yes, that’s the point. The FDA is not going to approve the combo BLA based on a 47 patient trial SO when efficacy at a higher dose was noted, the FDA recommended combing data from both trials for a more robust clinical section. Pretty simple understand unless NP is explaining it.
Yes, that’s the point. The FDA is not going to approve the combo BLA based on a 47 patient trial SO when efficacy at a higher dose was noted, the FDA recommended combing data from both trials for a more robust clinical section. Pretty simple understand unless NP is explaining it.
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