Good cautionary advice but, LPCN is no AGRX. They have met their secondary endpoints unlike LPCN. Also FDA have CRL'd AGRX, 12/ 2017 for a bogus adhesion concern. If they were to dream up any additional reservations don't you think they would have put it in that letter? The BMI issue is a labeling situation. Addressing that is not a reason to issue another CRL is it? There is just not much more to critique and delay. What else is there?
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