RE: question for Ivey6 May 2019 20:55
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