Earlier today, Pharmacyclics (NASDAQ:PCYC) announced it received a third Breakthrough Therapy Designation for ibrutinib from the FDA. It would seem each successive BTD is easier (or less hard) for PCYC to achieve than the prior one presumably because of the FDA gaining more and more comfort with the drug and more and more of an understanding of the drug's benefit with each submission.
Peter has said for some time Provectus enjoys a very collaborative relationship with the FDA. EOP2, the group within the FDA examining PV-10 for metastatic melanoma, also would examine PV-10 for HCC.
BTD Application #1 With Moffitt's data now in hand (i.e., poster and supporting materials), I think the company should have sufficient information to make a very strong case for BTD for melanoma.
BTD Application #2 Building upon the knowledge gained by the FDA from PV-10 & melanoma, once management has results of Provectus' contemplated expanded HCC Phase 1 trial in hand, I would think they should have sufficient information to make the case to the FDA for BTD for HCC.
BTD Application #3 Building upon the knowledge gained by the FDA from PV-10 & melanoma and PV-10 & HCC, and perhaps once management runs, say, a feasibility study for breast cancer, I would think they would make the case to the FDA for BTD for breast.