August 17, 2013

It All Begins And Ends With Rose Bengal

It All Begins And Ends With Rose Bengal. The paradigm shift in cancer treatment that is PV-10 is where my 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 Provectus shareholders.

PV-10, a 10% solution of small molecule Rose Bengal (“RB”) with an established FDA safety profile, 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 a number of solid tumor cancer indications, the drug generates tumor-specific immunity tantamount to in situ vaccination against cancer.

Ultimately, my investment thesis begins and ends with RB. There is no concern the safety of this active pharmaceutical ingredient ("API"), as there no longer any concern about the safety of PV-10 (in particular evidenced by the growth and regulatory acceptance of Provectus' compassionate use (expanded access) program.

The drug's clinical value proposition is straightforward: Oncology compound PV-10 is very safe, very efficacious locally and systemically, and very specific in its action. The drug robustly stimulates the immune system both locally and systemically, drug creates systemic anti-tumor immunity, is both a targeted therapy and an immunotherapy, works on multiple cancers, and has the potential to be used as a pre-neoadjuvant, a neoadjuvant, a monotherapy, an adjuvant and a combination therapy.

The fulcrum of PV-10's value proposition is its pristine safety profile, where the genesis of this profile is RB. Rose Bengal has an established safety profile with the FDA for prior human use as intravenous hepatic diagnostic Robengatope, approved by the Agency prior to 1982 (New Drug Application (“NDA”) Number 016224), and topical ophthalmic diagnostics Rosettes and Minims®. Rose Bengal has been used in liver function studies for more than 90 years.

A simple way of looking at it that PV-10 has a 30-minute "half-life," where half-life means "...the amount of time the compound is in the patient’s bloodstream before it is excreted in the bile. Rose Bengal is actually very stable in the human biological system, and although the portion remaining in the bloodstream is excreted rapidly in 30 minutes, the portion that has been absorbed by the cancer tissue actually remains in its parent form for weeks until the dying cancer tissue is absorbed by the body and the remaining Rose Bengal is excreted." (Source: Comment section, Investment Choices For Melanoma Awareness Month).

Investors often misjudge risk in the context of return. Just because a so-called safe asset or security could provide a safe return does not mean the expected return is commensurate (high enough) for the incurred risk. Conversely, a so-called risky security that may have the potential to generate a robust return does not mean the associated potential risk is commensurate (too high) for the amount of return expected.

Provectus’ stock’s risk-reward profile clearly is out of whack, and the return opportunity is more than commensurate with its potential risk. Nowhere is “risk-reward” better illustrated than by the drug itself: with a pristine safety profile and robust efficacy to date, PV-10 metaphorically is an investment fund with a high Sharpe Ratio (U.S. government bond-like volatility and equity-like performance).

Begin and end with safety. End, even better, with efficacy.

Blog Poll Question: What FDA Clarity Do You Expect By...? The poll results as of this post writing reveal several interesting things.

First, the expectation of clarity predominantly is breakthrough therapy designation ("BTD"), much like I wrote Provectus' whisper number is BTD.

Second, accelerated approval is what mostly is expected to come with BTD.

And third, clarity is more than likely to arrive in October.

Stating what should be obvious: In this group of voting shareholders and/or blog readers, there may be those who guess the outcome, and those who hope for one. And then there are those whose vote is informed by, at the very least, interacting with management. If management's wrong, voters (shareholders) will be wrong (and very disappointed).

I don't have to rely on my view of the situation. What is the wisdom of the subset of the crowd (and I can't really tell of course how big or small this portion of voters actually is) whose vote is informed?

Clarity from the FDA by October that is BTD, together with or followed by or that translates into accelerated approval.

If management's right, voters (shareholders) will be right (and very, very happy).

This week's stock price action. As a reminder, no one other than you and I care about this stock. And by caring, I mean buying. A novel compound, information for which is hard to come by, innovated by who again?, on a minor stock exchange with no Wall Street sponsor or institutional ownership means weeks like this past one (and there have been many more before this) happen.

Sellers sell Provectus stock for several repetitive reasons: I'm tired of waiting. I'm selling my common stock to hedge my preferred stock. I'm selling the common stock of my private placement units and keeping the warrants. I have to sell. Etc. Whether someone threw in the towel, got blown out (was blown out by their brokerage firm), merely was capitalizing on how Provectus raises money, and thus selling unrelated to anything with a negative orientation towards the drug or the company, this week simply provided another buying opportunity if one was so inclined. Thank you.

Growing expectations. Connecting several dots, not the least of which manifested themselves in the two blog polls above, regulatory clarity should be made transparent between now and October. That clarity decision also should be the key to unlocking what happens on the regional and/or worldwide licensure fronts and, perhaps, sooner rather than later the end-game. Wrong is wrong. But right is oh so right.

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