March 18, 2013
$PVCT: Where We Stand
With the sudden passing of my wife’s father, I’ve taken a much-needed opportunity to break away from the computer for a few days. As a result, I've had time to engage in introspection about my investment in Provectus. I’ll continue to do so during various spots before we return home.
Over time, several blog readers have asked how did I arrive at my decision and stock position. The essence of the investment thesis simple. The path to arrive at successful monetization, from an investor's perspective, is much, much less so.
Provectus continues to work with the FDA to obtain the Special Protocol Assessment (SPA) for the anticipated and pivotal MM Phase 3 trial. Management previously guided 1Q13 for its receipt. Although there remains about half a month in the quarter, I do not think the SPA will arrive before quarter-end.
A miss here -- that is, the SPA does not arrive by March 31st -- will disappoint some, make others angry or more angry than they already are, and open me up to criticism or further criticism. I understand.
Management might say that I, as a shareholder, have a six sigma (99.99966%) perspective of all things Provectus. My moment of clarity, due diligence-based, included among other things a deeper understanding of the regulatory path.
While we have been waiting for the SPA, and just recently, there have been discussions about the FDA's Breakthrough Therapy Designation ("BTD") and how it may apply to PV-10.
Provectus designed the MM Phase 2 trial to be suitable for Accelerated Approval (“AA”), particularly in light of how drugs like Allovectin-7 (Vical) and OncoVEX (BioVex, now Amgen) were treated by the FDA. Management, however, has of yet been unable to convince the Agency to allow PV-10 to follow an AA regulatory path. It is believed the data to support the drug's systemic benefit indeed is the requirement to be met.
We know the company received guidance from the FDA that it is appropriate to pursue regulatory approval via agreement with the Agency on an SPA. It appears the trial design parameters have been finalized; however, as I previously wrote, we still wait for the receipt of the SPA.
Provectus' ongoing compassionate use (expanded access) program indicates a very supportive FDA with regard to the use of PV-10. In the company's recent 10K filing, management wrote: "With more than 75 patients enrolled in seven centers across the U.S. and Australia, the protocol enables subjects to undergo more frequent and extensive treatments of PV-10 over a longer period of time than was allowed under the protocol used for the Phase 2 trials." There have been no reportable adverse events, and several stories of dramatic success.
Nevertheless, the appropriate trial design to support approval of PV-10 remains to be seen.
Recently, through certain congressional legislation, the FDA created a new pathway for drug approval, BTD, which looks like it acts as an umbrella to encompass existing SPA, AA and Fast Track (“FT”) pathways.
A shareholder speculated to me that because the SPA is taking its own sweet time and has exceeded several iterations of management guidance as to its receipt, Provectus is trying to change the subject by now pointing to the potential and prospect of BTD. While I too was initially disappointed in guidance setting related to the SPA, I do not think there is sufficient evidence or data to suggest management is obfuscating these matters.
Rather, there now appears to be a swifter path to market that leverages the historical work done by Eric, and his team of consultants and advisers, with the Agency. Stepping back, gaining perspective, clarity results.
Moffitt, as I have written in the past, by virtue of the kind of studies and tests the cancer center’s research team did and employed, respectively, are going to provide a key perspective on PV-10’s clinical relevance on April 8th at the annual meeting of the American Association for Cancer Research ("AACR"). This perspective is considered the missing link the biopharmaceutical industry – the FDA, Big Pharma, key opinion leaders (KOLs) and life science investors – has long sought for PV-10. Most especially and particularly, conclusive data is forthcoming that supports the drug's systemic benefit.
I think Moffitt’s work should be definitive in enabling Provectus to attain BTD, with the work undertaken to finalize a trial design under SPA with the FDA fully utilized in the form of a post-marketing trial. This path effectively is AA. I also think we will hear about this in Q2.