As of February 27, there have been 22 breakthrough therapy designation requests. Of these, 5 were granted and 5 were denied. Of the 5 Breakthrough Therapy designations granted: 2 were awarded to Vertex Pharmaceuticals for expanding the uses of its cystic fibrosis drug Kalydeco, 2 were awarded to Pharmacyclics and Janssen Research & Development for the cancer therapy drug Ibrutinib, and the 5th and last designation is unknown at this point in time.
Moffitt's full data set (delivered to the FDA by the beginning of April) would be quite supportive, very likely necessary and probably definitive in making the case to the FDA for this designation.
I presume Provectus has applied or is applying for Breakthrough Therapy designation. The question of when, of course, relates to the starting of the review & decision clock.
A 60-day or less time frame should bring a positive or negative decision by the end of May at the latest. This assumes application is made and, at the latest, is made concurrent with Moffitt data delivery, which I doubt; I think it would have been made earlier, but of course management has neither confirmed or denied action on this topic.
One way (designation obtained) or another (i.e., if management didn't get the designation, they'd have to explain why not), we could hear about this in Q2.
Ultimately, I find it interesting management's conversations have included, among other things, patient population, distribution network, and risk evaluation and mitigation strategies. If the nature of discussions have expanded to these matters, beyond protocol design & agreement and other trial oriented requests & demands (like CRO identification and contract review, or clarity and decision on imaging specifications), is "delay" really a delay?
An elevated level of discussion is to be expected with a novel compound that is producing such profound results.