December 7, 2013

Like Nothing Else

If you write, like I did, "PV-10, a novel oncology compound, exemplifies innovation over incrementalism, meaningful over marginal, productized technology over hypothetical, and changing the world over accepting the status quo, with not an insignificant amount of serendipity over contrivance. In sum, these form the quintessential essence of a paradigm shift in the treatment of cancer," you're placing an oncology treatment far, far above what is available to patients today and in tomorrow's pharmaceutical and biotechnology drug pipelines.

Of course, if you're Moffitt Cancer Center, how do you top, "Single injection may revolutionize melanoma treatment?"
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We approach, we think, a moment of [regulatory] clarity, where having asked (or shortly will formally ask) for outright approval, accelerated approval or a single arm trial, in that order (and, I assume, under the umbrella of breakthrough therapy designation), Provectus management awaits a decision from the FDA about the path forward for PV-10's approval. Anticipation has grown, and should continue to grow as we approach the middle to the end of the month; the share price has grown too: 34% over the last 3 months, 20% over the last one month, 13% over the last 5 days.

Through 2013, up until Moffitt's PR above, Provectus' share price was rather flat.
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In 2012, the stock fell considerably.
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But, with Moffitt's statement and PR, things changed; since August 22nd, the share price has risen dramatically. Moffitt Cancer Center, clearly an ardent champion for and supporter of PV-10, was the 19th ranked hospital for cancer by U.S. News & World Report for 2013-2014.

Other ranked hospitals, where resident key opinion leaders ("KOLs") exist who are supportive or in favor of PV-10 according to management, include Memorial Sloan-Kettering Cancer Center (#2), Johns Hopkins Hospital (#4), Dana-Farber/Brigham and Women's Cancer Center (#5), UCLA Medical Center (#11) and Duke University Medical Center (#18).
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Put into the context of a longer timeframe, like from the beginning of this year, the share price move is notable and noticeable (as is the increase in trading volume).
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Since 2012, too (again, notice the difference in daily trading volume, moving from left to right).
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And, since 2011.
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And, since 2010.
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Déjà vu all over again, or different this time? Sometime in April [I think] 2010 Provectus asked for accelerated approval ("AA"), at the end of April saying: Provectus Reports on Successful End-of-Phase 2 Meeting with U.S. FDA and Gains Clarity for Licensure of PV-10 for Metastatic Melanoma. While they were told no (on the merits of their argument for AA) and/or to elucidate PV-10's mechanism of action, the outcome seemed contrary to management's expectations at the time.

Sometime in December 2013 the company should ask for outright approval ("OA") on the merits of a vast amount of clinical data from Provectus' melanoma Phase 2 trial and Moffitt's melanoma Phase 1 feasibility study (Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10), some precedent (I think Perjeta for neoadjuvant breast cancer treatment) and, it seems, a collaborative relationship with a proactive FDA. It would seem the case for OA is considered strong. But if unsuccessful in gaining this desired outcome, Provectus then should ask for accelerated approval, with a positive result accompanied by a confirmatory study or additional confirmatory data. A single arm trial, "the final ask," might comprise 100 patients and a primary endpoint of progression free survival (although I'd be surprised if the trial was not halted after no more than 20 or so patients were enrolled and treated).

Assuming Provectus indeed gains clarity from the upcoming meeting or call with the FDA, it's not clear what if anything substantive management can or will say about it, via PR. The week of December 16th, or for that matter the remainder of the month of December, may come and go without significant detail about the clarity achieved.

It is interesting to revisit the title of Provectus' first End-of-Phase 2 meeting in April 2010, first noted above: Provectus Reports on Successful End-of-Phase 2 Meeting with U.S. FDA and Gains Clarity for Licensure of PV-10 for Metastatic Melanoma. I wonder what hint of guidance December's PR could give.

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