For readers who know me, you also know I'm currently on a family summer road trip, which I also refer to as our 4th annual Griswoldesque vacation. The road trip is a uniquely American rite of passage.
Dr. Agarwala's Munich presentation is at the end of this week, on Friday, June 22 (morning, Munich time). The MM P2 data being finalized, which this presentation marks, is important. Like Maxim noted on June 8, I [obviously] expect positive results. Much more importantly, I also expect such positive results to be very interesting.
My current expectation is the company could (should) report receipt of the SPA for the MM pivotal Phase 3 trial by the end of June, which is next week. It is possible we do not hear until the middle of July (I hope not much later than this). Management's current guidance is best case Q2 and base case Q3.
While Provectus' pursuit of the SPA for MM is designed around a clinical and business strategy to pursue approval for the intralesional delivery of PV-10 for local-regional treatment of Stage 3 and early Stage 4 MM, Moffitt's work is directly aimed at validating and further demonstrating the systemic benefit of the drug and therefore its use as such. This underscores the nature of the pursuit of accelerated approval for PV-10, a parallel path to management's work with the FDA to achieve the SPA. As a result, more information on Moffitt's work is very highly anticipated. Does Moffitt know their place in history?
While one cannot project timing of the regulatory path, one could argue PV-10 approval, now, is a certainty.
Craig is presenting at InvestTennessee on Thursday, June 21 at 10:45 am ET. Eric and Peter are in Munich.
The path to and timing of a dermatology deal likely will hinge on a review of the final psoriasis Phase 2 data by prospective partners as well as their take on the FDA's view of PV-10 toxicity or, more to the point, lack thereof. While it does not appear we're quite there yet, it does appear it might be soon.
The annual meeting is next Thursday, June 28 at 4 pm ET. If you have not yet voted your shares, you should. Voting allows you to voice your opinion of management and their approach, whether you agree or disagree with them, and agree or disagree with some or all of their business tactics and strategy.
Current cash balances, combined with likely monthly cash burn estimates, suggest a comfortable situation (operating runaway) for the near- to medium-term until one or more triggers or catalysts play out. Big pharma understands management has the ability to raise the money it needs (of course, money comes at a price).