question for Ivey6 May 2019 19:59
Hey Ivey, I have valued all of your recent input; Question: Would the FDA have issued the CRL if the ONLY issue is indeed related to labeling? Since there was communication back-and-forth during the review process, wouldn't the FDA have told Motif during the review process they would approve the NDA, but with labeling / restrictions? Or is it a mandatory step in the process to issue the CRL and discuss labeling at subsequent meeting? Would the FDA have a subsequent meeting to give Motif the option of approval "now", with labeling, or would Motif prefer to do some kind of small study now, to address concerns, so that the approval could be given in the near-future w/o any labeling? thanks