April 11, 2013

$PVCT: And Dr. Eric Wachter commented...

Eric's responsibility at Provectus comprises clinical development (e.g., trials, biostats, regulatory affairs, etc.), manufacturing and intellectual property (IP). In Provectus' PR about company research results at AACR, management inserted a quote attributable to Eric of "PV-10 is currently entering pivotal Phase 3 testing as a monotherapy for locoregional control of cutaneous metastatic melanoma." In the company's October 2012 ESMO PR, management wrote "The study duration is estimated to be approximately 30 months, with commencement expected in late 2012 or early 2013 following completion of review for SPA." The above describes Provectus' pursuit of the SPA since it first received guidance from the FDA to submit its Phase 3 protocol for review, either via standard review or a request for SPA in January 2012.

Eric and Provectus are pursuing paths to regulatory clarity with the FDA via the SPA and breakthrough therapy designation (whether that is fast track review, a more precise SPA or accelerated approval). I imagine Eric wants to make sure PV-10 is approved, which should include working hand-in-hand with the FDA to determine the best path for this.

The company has long said its primary customers are the FDA and Big Pharma. One would presume the FDA wanted to see Moffitt AACR data (presumably in the context of the fundamental local versus systemic paradigm shift). Now that they have, or when they do, the remaining clarity for shareholders is how and where the FDA directs Provectus to the eventual regulatory path.

No comments:

Post a Comment