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Alan Robert Ross
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I started investing while getting my Ph.D. at McGill University. My research was on behavioral correlates of neurological control of cardiovascular function. After 25 years as a Professor, I quit to do something more exciting and more difficult: live off of my investments. For quite some time, I... More
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  • FDA Meeting Provides Regulatory Clarity 12 comments
    Jan 28, 2014 12:42 PM | about stocks: PVCT

    I have run the short form of my interpretation of recent FDA events by Provectus management. I was told that my view is essentially the company view. Here is the statement:

    "The FDA meeting, which expanded the prospective indication for Melanoma and approved the application for BTD, provided the Regulatory Clarity that we, and Management, have been hearing about for so long, removing a significant impediment to the completion of licensing deals and ultimately a buyout."

    In the past, shareholders heard that the reason for not doing licensing deals was that, to get a fair price, PV-10 had to have Regulatory Clarity. Apparently, the Company views the results of the FDA Meeting to provide that for prospective partners. I presume that is because they have a number of interested licensees who were waiting for the FDA information.

    It therefore seems obvious that JV or licensing deals are closer to being consummated... as is the planned eventual sale of the company.

    Disclosure: I am long PVCT.

    Stocks: PVCT
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Comments (12)
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  • Dennis R. Mahon
    , contributor
    Comments (390) | Send Message
     
    Thanks TI... good job, man.
    28 Jan, 01:08 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » My pleasure.
    It is comforting to know that we won't be waiting for Regulatory Clarity anymore, at least about licensing. Now I suppose the question is price and terms in any deal.

     

    Critics see not making a deal already, before Regulatory Clarity, as a negative, because they see everything as a negative.
    Critics presume that no deal means no OFFERS, because that fits their bias. It could also mean that Provectus had offers but preferred to wait until the offers reflected the value of the license more, rather than reflecting that there was yet insufficient Regulatory Clarity.

     

    As a shareholder, I see waiting to get the best price as being smart and making too cheap a deal, just to get one done, as foolish squandering of shareholder value.
    To take a neutral stance, we can just admit we don't know of any offers and await further developments.
    If Provectus Management has had a realistic reading of the situation all this time, we should see deal announcements start to happen in the not-too-distant future.
    28 Jan, 01:37 PM Reply Like
  • bradpitt83
    , contributor
    Comments (8) | Send Message
     
    thank you for sharing your opinion.
    29 Jan, 06:59 AM Reply Like
  • RandolphDuke
    , contributor
    Comments (17) | Send Message
     
    Would love to get your thoughts on something. From what we know and are being told, pv-10 has the potential to "destroy" or "kill" cancerous cells. Yet many of the videos from the doctor's and scientists, and from statements by the company, it seems like their market design for the drug is on attacking "symptoms" of melanoma (e.g., puss, pain, discomfort), rather than acting as a "cure." Do you think provectus is downplaying the drug's potential to get to market quicker? Thanks.
    29 Jan, 09:14 AM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » Amouflage, I never got that impression.
    Give me a link so I can see what you mean.

     

    I think the company is required by the FDA to not state any effect that is not thoroughly established to the FDA's satisfaction. The FDA in the Minutes (and the meeting) seemed to tell PVCT they wanted MORE on the side effects. Apparently because this is a major benefit over the more damaging and sometimes life threatening side effects of other chemo or immunotherapy.

     

    Certainly you will not see the company ever talking about a "CURE" because that is an efficacy claim that is noy well enough established for the FDA to allow them to use it. And if you are smart, you don't cross the FDA/
    29 Jan, 09:27 AM Reply Like
  • RandolphDuke
    , contributor
    Comments (17) | Send Message
     
    Sure. I take it these are easy to criticize because they are dated, but it seems to be a consistent theme concerning the drug's potential since as far back as I could find. I've read more current interviews where the doctor's are saying the same thing, i.e., the drug has potential to help with the discomfort, etc.

     

    http://bit.ly/1d8Oyqr

     

    http://bit.ly/1a1n9Kt

     

    Moreover, and I know the worst source of news possible, but Adam Feurestein's third article mentioned that when he talked to Pete Culpepper that Pete told him that the drug's focus was on the symptoms of melanoma.
    29 Jan, 09:37 AM Reply Like
  • RandolphDuke
    , contributor
    Comments (17) | Send Message
     
    I guess what I'm saying is, in the end, is this really a wonder drug for cancer that destroys tumors? Or is it a drug to help ease the pain of dying?
    29 Jan, 09:38 AM Reply Like
  • nicksanta
    , contributor
    Comments (241) | Send Message
     
    Amouflage,

     

    Symptoms of melanoma are moles, freckles, etc that change in size, shape or color. They become a melanoma. So I guess you can say any drug treating melanoma cancer is targeting the symptom. But the are one in the same. PV10 is injected into tumors. Period. As your video links show, they kill the cancer cells.

     

    Moreover, this is directly from the front page of the Provectus website:

     

    Provectus Biopharmaceuticals is developing advanced therapies designed to target and destroy the deadliest cancers – melanoma, liver & breast – while eliminating side effects.
    29 Jan, 10:02 AM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » The patients in the clinical trials were stage 3 and 4 who had failed a median of 6 other treatments. There were on their way to die because they had a high tumor burden that was not eliminated by conventional means. With the new FDA indication for Recurrent Melanoma, earlier stage patients will be treated and be less likely to eventually die from Melanoma.

     

    In the first video, Dr. Thompson, explains that he used PV-10 because he wanted to spare the patient's arm (from surgery that would ruin his ability to use it) and "to kill the tumors without doing too much damage to the normal tissues".

     

    In the second, Dr. Agarwalla talks about PV-10 shrinking tumors and not affecting normal tissue and helping untreated tumors, while they interview the patient about the absent side-effects, not the Dr.

     

    I see no problem.
    The drugs works to kill cancer in at least two way AND it causes less, almost no, side-effects (which can kill patients with some chemo drugs).

     

    This is not something to be wary about.It is something to be happy about. And it is likely one of the reasons why the FDA is not going to be afraid they are making a mistake when they approve PV-10 for treatment of (eventually) many kinds of cancer. The drug appears to be both safe AND effective.
    29 Jan, 10:06 AM Reply Like
  • RandolphDuke
    , contributor
    Comments (17) | Send Message
     
    Thanks for the replies, quite long here, gl2a
    29 Jan, 10:08 AM Reply Like
  • YellowHair
    , contributor
    Comments (9) | Send Message
     
    What is going on with the PVCT share price today?!? No news whatsoever and its getting hammered!
    30 Jan, 01:03 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (421) | Send Message
     
    Author’s reply » It looks like another attack by the blood-sucking shorts that proudly make their living by hurting companies and their shareholders.

     

    The Company is working on licensing deals and there are research reports due out that will remind people that the fundamentals don't justify this kind of selling... and instead, justify buying.

     

    The possibility of good news may have made the shorts attack, with large sell orders, so that they panic the public and then can cover before news is released.

     

    Of course the timing of deal-making and when researchers make their results public is unpredictable and not in the full control of Provectus.
    30 Jan, 01:24 PM Reply Like
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