August 14, 2012


In the grand scheme of things the receipt of the SPA from the FDA (for Provectus' pivotal MM Phase 3 trial) is one step, of many, on the path to the widespread use of PV-10 to treat cancer.

Yet, [at the risk of pushing the analogy too far] the SPA acts like a falling domino, nudging other dominos to fall (happen):
  • Some life sciences funds buy the stock, now that the company has an SPA;
  • The stock moves to the NASDAQ;
  • More life sciences funds buy the stock, now that Provectus trades on a major stock exchange;
  • Within a month or so, the MM Phase 3 trial begins;
  • Much greater national media interest, now that the Phase 3 trial has commenced and the stock trades on the NASDAQ;
  • etc.
Given the manner in which the FDA and Provectus have been communicating and collaborating, I have long thought management reached agreement with the federal agency on the SPA. What remained was a company issued-PR to make it "official." It appeared to me there were two communication tracks: regular management interaction with agency staff to collaborate on the final design, and design submission that started the so-called 45-day clock.

I have no ability to assess the precise timing of events.

When did the first communication track (i.e., bilateral talks) end? And when did the second track (i.e., design submission)?

I think management only would submit a design it had full confidence eventually (i.e., after 45 days) would be approved. Given the collaborative nature of management's interaction with the FDA, I don't think it is unreasonable to believe or assume Provectus reached a verbal agreement on a final design (i.e., a design suitable to submit for approval that ultimately would be approved).

But when did management reach a verbal agreement? Probably in or around June, before the Munich presentation. In this presentation, as I previously blogged, the final trial design was shown:

If you followed the presentation of this slide since 2010, you will have clearly observed its development, maturation and finalization.

So, when did management submit the final design and start the 45-day clock? If they submitted the final design in late-June, we'd probably hear about it in mid-August.

August typically sees illiquid capital markets as traders and investors are away from their desks. The impact of an SPA PR, this month, could be muted by vacationing market participants. Perhaps we'll read the PR after Labor Day.

While I'm not going to go into detail about the underlying assumptions and rationale of what follows, the observation itself [to me] is very meaningful, historically (at the time), cumulatively (over time) and, in particular, now. I previously blogged on my assessment of the players' individual backgrounds. personal situations and financial wherewithals.

Why has Eric -- the most prolific exerciser of stock options (and purchase of the underlying security), the company principal most intimately involved with clinical trials and data analyses and the company principal most intimately involved with FDA regulatory path discussions -- stopped exercising options, completely, in 2012? In large part, to prevent any aspersion to be cast about his stock-related actions in relation to whatever [positive] information he has or will have.

In the end, I am not going out on much of a limb to write "the company, in my view, has received an SPA for its pivotal MM Phase 3 trial." Management's base case guidance, for some time, has been Q3. So whether the related PR arrives this week or shortly after Labor Day, it is coming, and soon.

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