August 12, 2012

Are We There Yet?

It seems to me two items are unresolved in the minds of life sciences investors who remain on the sidelines but interested in Provectus.

How quick is the path to regulatory approval for PV-10? The SPA provides one measure of speed and time under the contemplated label. Accelerated approval provides another.

How big is the opportunity for the drug? The opportunity, of course, is the recognition of PV-10 as a systemic agent, not simply a local one. Further Moffitt data, both murine and human studies, should dispel any lack of comprehension.

Without answers to these questions, there is not sufficient rationale and impetus, for the most part, to buy shares (or, at least, a lot of them).

Management reiterated its base case guidance of Q3 for receipt of the SPA. More Moffitt results should be available some time in Q4 (perhaps, I speculate, as early as ESMO 2012, which runs from September 28 to October 2). On the one hand, both Big Pharma (including Pfizer in the pole position) and life sciences investors wait. And so do the rest us. Are we there yet? No.

Big Pharma: No one moves, including Pfizer, unless someone moves. Game theory.

On the other hand, Dr. Craig Eagle and his counterparts at Johnson & Johnson, Novartis, Roche, Bristol Myers, etc. fully understand the so-called perfect storm facing their companies: the patent cliff, which saw and will see an estimated $250 billion in sales become at risk between 2011 and 2015. Drug replacement costs, drug approval times and risk of approval failures exacerbate the situation caused by the patent cliff.

Big Pharma:
 Someone moves, including Pfizer, because they have to move. More game theory.

 Are we there yet? Perhaps. If Big Pharma thinks Provectus will get its SPA and, in many corners, acknowledges the implications of Moffitt's results, all it takes is a phone call to Knoxville.

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