December 18, 2013

The FDA (What Does the FDA Say)

Chief Executive Officer Craig Dees, Ph.D., said, “This meeting with the FDA is a significant step forward in establishing a pathway to initial U.S. approval of PV-10 for the treatment of melanoma. There are different possible routes to approval of PV-10 such as a breakthrough therapy designation or accelerated approval, and each of these has different requirements and time lines. I appreciate that our shareholders are eager to receive as much information as possible, and while there is nothing more the Company can add until it has received the official meeting minutes, we wanted to provide this interim update. In addition, our discussions with several potential international licensing partners are not affected in any way.

Bold and underlined emphasis is mine.

A material event to management, and thus to shareholders: Associated SEC filing here.

[Updated 12/18/13]: What wasn't said is as or more important as what was. Provectus' PR today included mentions of "breakthrough therapy designation" ("BTD") and "accelerated approval" ("AA"). There was, however, no mention of "a Phase 3 trial" or "a special protocol assessment" ("SPA"). While the company, it seemed to me, told the market PV-10 was "up for" either BTD (a categorization or "gold star" providing more and faster interaction with Agency personnel, and not a pathway onto itself) or AA, it also seemed to me management told the market there was no need for or consideration of a Phase 3 trial.

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