Pinned straw:
@raymon68 given that addressing the CRL required additional data and/or analysis, this almost certainly makes the resubmission a Class-2 resubmission. The standard timeline for that is a 6-month review clock. Having Orphan and Fast Track status does not necessarily change that clock. Nor has there been any information to indicate that Pixclara will receive Priority Review.
How, having said that, it is entirely possible that the FDA do reach a decision earlier. It possibly comes down to how material the new information is to the decision as well as how important the FDA considers approving this new first-in-class drug.
So, my base case expectation is that the timeline here is 6-months, even though I believe there is some commentary in the market that it could be fast (e.g. Head for the Cure Foundation being "hopeful of an expedited review".) A positive earlier decsion would be a positive surprise.
On chances of success, on a statistical basis, Class 2 resubmissions have a 70% - 75% chance of success. (Generically, the pass rate is 60% - 75%, but with an imaging agent, we should be at the upper end of that.). This is lower than the initial NDA pass rate at the final hurdle. Basically, if you don't clear the hurdle at the first jump, your chances of clearing at a subsequent attempt are diminished. Of course, that's an industry average, generic kind of assumption. Who knows where Pixclara stands.
Disc: Held