> DNDN – If you know your BLA is rate-limited by a CMC section that won't be ready until Q4, why bother rushing the clinical section? What strategic or other value do you get by submitting the clinical section early given the FDA is already overwhelmed with filings?<
If DNDN truly thought that the 9901 + 9902a data set was sufficient for approval, there is no way in hell it would take 18 months from the end of the phase-3 trials to get manufacturing ready.
The reason it’s taking so long to get manufacturing ready is that DNDN knows there is no urgency; there is no urgency because (behind closed doors) DNDN does not believe that the current data package is sufficient for approval.
It’s really that simple, IMO, but simplicity probably doesn’t sell newsletters.
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