November 19, 2011


So what's the punchline? To SPA, or not to SPA?

I believe Provectus will agree with the FDA on a consensus design for a pivotal Phase 3 for MM suitable for an SPA (did I say that right?). But, I also believe Mr. (or Ms., your choice) Market thinks that, at worst, the company will not get this SPA. At best, Mr. Market thinks that, I believe, agreement will not happen anytime soon.

Management views the situation in a somewhat or slightly more nuanced way:
  • First, it isn't a question of if, but rather when. Life science investors expect Provectus will get the SPA, but they won’t believe it (read: buy shares) until they see it (read: get it);
  • Second, what. It’s not just about getting an (the) SPA. More critically, it’s about the details of the design (endpoint(s), and number of patients, etc.); and,
  • Third, it's about the very critical understanding of the immunology that has resulted from Moffitt’s work.
Fair enough on the first point. Points two and three require most discussion in subsequent posts.

I don't think management has a precise time frame about when they will agree on the SPA with the FDA. While the expectation is, literally, any day now, they express the sentiment that they've done all they can.

They wait. We wait.

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