CRL Content16 Feb 2019 18:51
Don't usually post, but heavily invested and silently praying.
The electron CFR contained within the FDA website, gives you the list of prescribed information that the CRL should cover.
They should tell you clearly why it has failed and , if poss, tell you how to correct any specific failing within the application. If it was labeling, or some administrative error then I think MTFB would have been clear about that. They can release a CRL without considering labeling at all(as far as I know). So fingers crossed that it can be resolved as I was 100% sure it would get accepted.