December 15, 2013

"But I have promises to keep, and miles to go before I sleep..."

Provectus management is far from finished: They certainly have promises to keep, and miles to go before they can sleep. They know this.

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In the face of "no news," the stock price has more than doubled since November 1, 2013. One press release:
Three "In the Media" releases:
Four Provectus News e-mails:
  • PV-10 in Advanced Melanoma: High Response Rates, Evidence of Systemic Response, November 27, 2013,
  • PV-10 continues to show robust effect in cutaneous Stage III-IV melanoma, November 20, 2013,
  • Meeting Highlights: 2013 European Cancer Congress, November 18, 2013,
  • Locally developed cancer drug shows 'promising results,' November 7, 2013, and
  • Provectus to Hold Special Meeting of Stockholders December 16, 2013, in Knoxville, Tennessee, November 5, 2013 (not October 24, 2013 as distributed).
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    Did something happen that I missed? Or is something going to happen? One press release in the last 45 days or so, yet more than a 100% increase in the share price, the highest volume day (per Yahoo! Finance) at 4.5 million shares traded, and two (#1, December 13 and #4, December 12) of the top ten volume days in company public markets history.

    #8, September 20 and #10, September 30, 2013 were possibly understandable, given Peter's The Wall Street Transcript and The Life Sciences Report interviews on September 16th and 19th, respectively. I'll discuss the memory of #2, September 6 and #9, September 18, 2007 below. One can delve into the stories, or lack thereof, for the other 4 dates, but my message of last week (really, the last two weeks) is the clear, unequivocal surge in share price, traded volume and blog readership (as I've repeatedly said, a digital proxy or indicator of drug, company and stock awareness).

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    Speaking of blog readership, I compared key stats for the first fifteen days of December to those of the first fifteen days of the last four months. 50-70% increases in the number of unique visitors (i.e., different IP addresses). 30-40% increases in visits. 60-120% increases in page views.

    Have we been here before? Some people are inclined to think so, comparing the share price of the last few days and weeks to Fall 2007.
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    I marvel at a Provectus PR about a year earlier (than 2007): LEADING MELANOMA SPECIALIST VALIDATES ABLATIVE ABILITY AND SYSTEMIC EFFECTS OF PROVECTUS ANTI-CANCER AGENT PV-10, September 14, 2006 (why are they shouting?).
    Professor Hersey characterized the results achieved through PV-10 as remarkable, particularly because of the apparent systemic effects of the agent. While further study is needed, Hersey said that PV-10 ablation of the treated tumor appeared to elicit an immune response leading to destruction of untreated cancerous tumors, a response often called the bystander effect, while leaving healthy tissue intact. 
    "We may have found an Achilles heel of these tumors," Professor Hersey stated. "Many who were originally skeptical now believe we have something here. PV-10 appears to function by a novel mechanism that selectively targets the lysosomes of cancer cells, leading to rapid necrosis of treated tumors. This results in destruction of the tumors and may explain its systemic effects. Hence, PV-10 may represent an important new category of oncology agent. Whether it is a major breakthrough in cancer treatment deserves further study. But we have already seen some very impressive responses."
    Bold and underlined emphasis above is mine.

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    2007 seems a lifetime away, before the 2007-2008 financial crisis, which goes by several names and whose time period can be shorter or longer depending on your perspective. Capital markets (e.g., behavior, liquidity, participants, etc.) were different then than now, in a number of ways.

    Did spoken and unspoken words warrant the share price's September run-up? Did lack of words following it, or lack of followup more generally, bring the share price hurtling downwards thereafter? Is this time different? I think yes, and also no. Company principal investigator and Hersey conveyed what management had known for a long, long time: the beneficial local agent had systemic benefit.

    Fast forward to 2013.
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    Moffitt Cancer Center's PLoS paper Intralesional Injection of Rose Bengal Induces a Systemic Tumor-Specific Immune Response in Murine Models of Melanoma and Breast Cancer.
    ...This study was undertaken to elucidate the apparent immune mechanism of this systemic effect following lesion ablation with PV-10...These studies have demonstrated that intralesional PV-10, in addition to reducing the growth of a directly injected tumor, leads to the induction of a robust anti-tumor T cell response and supports the use of PV-10 to induce systemic anti-tumor immunity for the treatment of metastatic melanoma and breast cancer.
    Bold and underlined emphasis above is mine. No, it's not different this time, but yes, Moffitt's further study and validation has assisted Provectus immensely.

    Management has said, for some time, what they view as regulatory clarity will be communicated before year-end. Let's see. Clarity, or put differently the "FDA's voice," I think and believe, is essential for the next phase of the company.

    A day, December 13, 2013, where trading volume was nearly 75% higher than the previous high of more than six years ago, September 6, 2007 is, of course, notable. A closing share price of $1.54 on Friday, more than 100% higher than a closing share price of $0.76 on November 1st is, most certainly, dramatic. But, management, the company, the share price and shareholders have more miles to go before we collectively can sleep.

    It's more than just next week, or the rest of this month and year. It's January, and February, and Q1, ..., of 2014.

    The FDA and regulatory clarity, and [where Provectus is in] the regulatory process.

    Regional transactions in China, India and/or Japan.

    More Moffitt pre-clinical and clinical data, pronouncements and publications.

    Pfizer, where art thou?

    A NASDAQ CM listing?


    Yes, it's different this time.

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