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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
Wow ! That’s a long question ? Is it a Trap ? I have my binoculars on again.
Hey all. Just picking up on that post. My understanding is the FDA don’t offer initial feedback after the CRL. The onus is on the company/sponsor to request a Type A meeting, and any comments are made at the actual meeting not within the CRL (unless there is a pre meeting) which in this case there was not. I found the Q&A link on these meetings helpful. It seems a very prescriptive process and nothing further discussed until the Type A meeting https://www.accessdata.fda.gov/cder/sb-navigate/topic3/topic3/da_01_03_0300.htm
Evening All
Hope everyone had a good Bank Holiday.
Is possible it could be about labelling.As the labelling part is sorted fairly late in the NDA review then may have been limited communication between the two before the CRL.
However,can’t be 100% sure.All I know is MTFB were very surprised at issuance of CRL and believe they have a compelling case moving forward.
Is more of a mandatory step to issue the CRL especially given the shutdown.
At the Type A meeting held last Friday it is possible the official minutes could suggest labelling changes but my understanding is a new NDA needs to be submitted.
At the AGM I will hopefully have a much clearer idea of what was covered based on what they say and conversations with the BOD.
Sorry I can’t give a more complete answer but MTFB are very circumspect at the moment about what they are saying and the AGM is the big opportunity to try and get a better feel for the way forward.
BW
Ivy, thanks for sharing your knowledge please keep it sharing, very helpful.