Awakening

Labor Day weekend kicks off what may well turn out to be a tumultuous September, historically the worst month of the calendar year for the stock market. On tap, among other things, are a decision on the new Fed chairman, the expected commencement of Fed tapering, the August’s jobs report, a possible government shutdown (in the absence of a new budget), the debt ceiling debate, a likely U.S. military strike on Syria, and the possible further crumbling of emerging markets like India, Indonesia, etc.

Then, there’s the fall and Provectus. I think anticipation of what the near-term holds for the company grows: FDA? BTD? What comes with it? China? India? Other? Etc. We simply have to wait.

Moffitt’s press release, in many ways, began a new chapter in the awareness of Rose Bengal, PV-10 and Provectus. The PR was well circulated, garnering attention and generating several nice headlines, among them:

• Moffitt Cancer Center study could offer hope to melanoma sufferers,
• Injectable dye could be agent to end melanoma,
• Single dose of injectable dye could help make melanoma history, and
• Injectable Dye PV-10 Could Reduce Tumors Size.

More discourse could be found on Twitter, here and here. As I most recently wrote, this is just the public discourse the company and stock need to and should have, as folks of varying influence following and opining about the biotechnology sector start, I hope, weighing in more frequently and regularly on PV-10, Provectus and the stock.

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"Connecting The Dots" blog readership stats are up. Readership of the blog hit new highs in August with unique visitors (1,182), number of U.S. visiting cities (414) and total number of visiting cities (497). Understandably, page views (7,421 in August) and visits (5,820) are down from May (8,578 and 6,178, respectively) when unique visitors set a previous high of 1,130. I wrote 59 posts in May, but only 7 in July and 9 in August (after averaging 36 a month from November 2011 to June 2013). I believe the blog is a proxy for awareness of the company.

Awareness continues to grow. There is no denying it. This of course must, and ultimately should translate into a higher share price when regulatory clarity is made transparent.

Nevertheless, it's informative to see Big Pharma, Big Biotech, Regional Pharma and well-known U.S. hospitals (e.g, Amgen, Memorial Sloan-Kettering Cancer Center) continue to visit the blog. Even Moffitt folks are regularly visiting now.

Judging by their Google search, it would seem the Amgen folks are carrying out due diligence on PV-10's mechanism of action.

As an aside, I re-calculated readership stats on a month-to-month basis using Google Analytics, which resulted in different and higher numbers. Previously, when I lasted presented data through June 30, 2013, I used cumulative figures to determine monthly ones (i.e., August monthly figures = August cumulative figures - July cumulative figures), rather than simply tabulate numbers each month.

It seems to me management's strategy is to let Moffitt do the talking about PV-10, at least now. Discussions and perspectives like Dr. Philippe Aftimos, MD above are relevant dialogue, and can be more substantive and constructive when appropriate clinical data is available for him and others to further comment on and critique. This will happen when Moffitt starts talking more about PV-10. There also is ECCO 2013, where a poster presentation will be made (the abstract should be available mid-month for review).

For example, at the end of September, Moffitt is hosting a one-day educational and scientific meeting entitled Update for Clinicians on Diagnosis and Treatment of Melanoma and Other Cutaneous Malignancies. According to the program's description, the meeting will "...focus on key clinical topics in the management of melanoma and other cutaneous malignancies, including evolving standards of care and current guidelines, as well as the most promising novel chemotherapeutics and targeted agents currently undergoing clinical trial evaluation." Co-chaired by Moffitt' Drs. Vernon Sondak and Jeffrey Weber, with financial support by Delcath Systems, Genentech and Provectus, there is expected to be commentary on and inclusion of PV-10 at the meeting.

Moffitt's publication of its Phase 1 feasibility study is expected in early-2014. Anecdotally, a Stage I patient, for whom it was planned to undergo surgical resection, was treated with PV-10 and required no surgery. One such patient, of out at least 15, is an observation, not a conclusion, but it would seem fair to write, based on the balance of information accumulated thus far, there is no denying the Moffitt folks' excitement about PV-10.

Views of Moffitt's PLoS paper were up more than 80% month-over-month. That's a good thing, but more is better: more data, observations and conclusions about the pre-clinical and clinical work Moffitt has done but has not yet fully revealed.

Peter should be traveling to China this week. Of the two lead parties, one appears very motivated to get a deal done. The question, then, is whether Pete returns with an MOU or better, or not.

At least one Indian party also is very motivated to do a deal.

In the cases of both China and India, I trust the company is balancing the need, value and import of commercial validation, in these cases regional in nature, with the opportunity of regulatory clarity that is accelerated or outright approval via breakthrough therapy designation ("BTD").

The share price faces capital structure-oriented headwinds as it tries to make a sustained move upward. There was a rumor of Network 1 Financial-based selling last week into the buying interest sparked by Moffitt's PR and Agora Financial's newsletter.

If true, one would imagine the rationale for such was something to the affect of selling the common stock portion of the private placement units and keeping the warrant portion. Network 1 and their clients are an important constituency because of the number of shares and warrants they cumulatively hold. These shareholders, both the firm and its clients, can help or thwart a rising share price around these levels (recent placements were priced at 75 cents per common share) and higher (according to Provectus' corporate presentation, the net exercise price for warrants is $1.05). I expect these folks to do what's in their respective own best interests, which is to sell now and sell later, as the share price attempts to breach higher and higher levels before the $2 up-listing threshold and shortly thereafter.

It's also possible there was conversion and sale of Provectus' preferred stock. Whether common or preferred, this selling will continue to weigh on the share price as it endeavors to rise, until it doesn't.

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The BTD application should have been submitted by now.

I took down the blog's poll on August 25, which was earlier than I had intended. By then, the poll had served its purpose, which was to gauge shareholder sentiment about the prospects for and timing of regulatory clarity, albeit based on the offered choices.

There is great anticipation of BTD, followed by the expectation of accelerated approval coming with it (concurrently or subsequently), most likely in October.

What's not to like, or love, about the fall?

School. University. College football. The NFL. Pumpkin spice lattes (for my mom, when she visits). The changing colors of the leaves.

And, for me, anticipation of the company's next stage in its development.