The regulatory journey on which the company has embarked appears to me to have two paths, which are not mutually exclusive nor unrelated. The paths also provide insight into the timing or catalysts for when Big Pharma might move on the Provectus.
The SPA. See recent related posts here (Current SPA Guidance) and here (Time Taken for the SPA). Current management guidance on the receipt of the SPA appears to be Q2. With Moffitt MOA and Provectus combination therapy results in hand, both demonstrating systemic potential, all that should be needed by Pfizer or other Big Pharma to buy Provectus would be interim MM Phase 3 trial data. Recall in BioVex's case, Amgen moved on the company when OncoVex demonstrated systemic potential and interim MM Phase 3 trial data was available.
BTD. A much more catalytic outcome when the end of this path is reached, there's work to be done here. Management (i.e., Eric and his team) must file the application (i.e., make the request) for BTD with the FDA. This scenario could play out like this: The FDA grants Provectus BTD for PV-10. An accelerated path to market in a manner similar or equal to accelerated approval materializes. The SPA, should it be received prior to BTD being granted, is turned into as a post-marketing study (Phase 4 trial). Pfizer or another Big Pharma buys the company thereafter.
No comments:
Post a Comment