August 3, 2013

The #OhShit Provectus Moment

Bell lap. You may recall I wrote in early-June, a couple of months ago, that I believed the focus of Eric and his regulatory affairs team was on getting PV-10 approved (my post entitled $PVCT: Do You Understand the Words That Are Coming Out of My Mouth?). I thought Eric et al. were working collaboratively with the FDA to provide what additional information was required by the Agency to achieve accelerated approval ("AA"). I felt to me the situation wasn't/isn't about SPA or BTD applications or submissions, or timing, anymore. Rather, I felt, it was/now is just about getting PV-10 approved (e.g., label, patient population, remaining boxes to check, etc.).

But, all drug development companies and their management teams try to get their drug candidates approved. You follow steps in (i.e., meetings with and submissions to the FDA) and out (e.g., conferences, peer-review publications, meeting with and engaging key opinion leaders, etc.) of the regulatory process and the investment one (e.g., soliciting or seeking out investment sponsors, playing nice with Wall Street, etc.).

Provectus hasn't really followed a lot of those "recommended" steps. Typical of an atypical biotechnology company management team, but I think typical of the best folks coming out of this country's national labs (at least, the several I met in a previous lifetime), they followed a data-driven process rather than one driven necessarily by convention or tradition.

In doing so, you make choices and decisions that don't always work out or that require changing course or that take more time than you would have liked. You learn, you get better, you adapt, you continue your pursuit, especially when the data gets better and more expansive over time.

So when I write "Eric is focused on getting the drug approved" I mean his efforts, and those of his team and the rest of management, to answer all of the FDA's questions from 2010 through this year that previously had resulted in Provectus getting "shot down" or put off when they first asked for AA.

As such, there will come, I think and hope very soon, an "oh shit" moment when, in my view, Provectus gets breakthrough therapy designation ("BTD") for PV-10 and metastatic melanoma ("MM").

The investment community, broadly speaking, says "oh shit" as a natural reaction to four guys from Tennessee innovating PV-10, getting BTD for MM, an investment opportunity seemingly out of nowhere and not on most investors' radar screens or in their stock filters, impressive clinical and business value propositions that beg for more exploration and examination, and so on.

Perhaps "oh shit" also comes from a realization that PV-10, a 10% solution of small molecule Rose Bengal, is a very safe and efficacious therapy that when injected into accessible cancerous lesions rapidly reduces local tumor burden and stimulates the immune system to systemically shrink or eliminate non-injected distant tumors and visceral metastases. Broadly applicable to several solid tumor cancer indications, the drug generates tumor-specific immunity that is tantamount to in situ vaccination against cancer.

Or from the understanding that Provectus and its management team exemplify innovation over incrementalism, meaningful over marginal, productized technology over hypothesis, changing the world over accepting the status quo – all of which combine to form the quintessential essence of a paradigm shift.

Or from the construction that the paradigm shift in cancer treatment that is PV-10 is where a compelling investment thesis begins and ends: a novel compound, a ready made product, a vast addressable market of unmet need easily, profitably and fully met over time. The thesis comprises compelling clinical, regulatory, business and stock value propositions in a pharmaceutical industry ravenous for safe and effective oncology product offerings, facing an addressable market with an annual growth rate exceeding other therapeutic areas, that following drug approval delivers a lucrative monetization for shareholders.

As for timing, well, you won't get a revealing word from management on the topic, other than encouragement to read May's CEO letter. I think it's reasonable to speculate around or before The European Cancer Congress 2013, as I've previously written in blog posts "Raising the Curtain on $PVCT, Finally" and "$PVCT's Word out of the 8th World Congress of Melanoma," because you can't help but think, after observations following the 8th World Congress and during this week in New York, that the BTD application has been completed and/or submitted.

Pfizer. Peter was said to have been in several meetings with folks at Pfizer this week. As you know, Pfizer announced this week it would reorganize "its commercial operations into three new units, with one division focused on products that are losing patent protection, one division that will handle drugs with years of patent protection remaining, and a third that will sell vaccines, cancer treatments, and consumer products."

What positive or negative effects does or could Pfizer's reorganization have on Provectus? I am interested to learn of corporate advisory board member Craig Eagle's go forward role, if any, in the new corporate structure at Pfizer. I had asked a former senior executive at a global brand for the internal view of Dr. Eagle within Pfizer. It was interesting to compare notes in the context of what emerged this week from shareholders who were updated in New York. I also learned of a "closer relationship" (that I do not believe includes any monetary concepts) being contemplated between the two companies. I'll dish next weekend on this, and on things Pfizer because I'm interested in (albeit, as a non-biotechnology investor, a tad perplexed by) the tapestry apparently being woven. You can't help but think there's not a small amount of table setting going on, which isn't to say other options, outcomes or relationships with others are being foreclosed.

PH-10. Why was/is Eric also in New York this week? It is possible he was involved in continued due diligence by regional and/or global pharmaceutical companies. His portfolio of responsibilities at Provectus of course comprise clinical trials, biostatistics, intellectual property, regulatory affairs, and manufacturing.

With regulatory affairs resources having been recently shifted towards PH-10 and the company's inflammatory dermatoses opportunity, he also may have been visiting with researchers at Rockefeller University's Laboratory for Investigative Dermatology (where toxicity-related work, among other things, was being conducted) and principal investigators at Mount Sinai School of Medicine (PIs for the company's atopic dermatitis and psoriasis trials).

A change to the layout of the blog. As you will have seen, I made a layout change by adding a pane on the left hand side to provide snippets of news, information, data, rumors, etc. I find, glean, learn of or hear.

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