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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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  • Mea Culpa: The FDA And I Have Different Assumptions 18 comments
    May 24, 2014 7:59 PM | about stocks: PVCT

    PROVECTUS AND THE FDA BTD APPLICATION

    The rejection of the application for Breakthrough Therapy (BTD) designation for PV-10 is tragic for the people suffering from cancer that will die waiting longer for a drug that works well without nasty side effects. And it is certainly negative for those of us with large investments in Provectus, although it is likely only a postponement of our profit.

    The FDA acknowledged "the reduction in the size in one to 10 target lesions in patients with locally advanced melanoma, who may have additional untreated cutaneous, subcutaneous, or visceral sites of disease."

    They indicated "clinical data provided in your request for Breakthrough Therapy designation are indicative of drug activity in the treatment of local, satellite or in-transit recurrence of malignant melanoma".

    This means that the FDA acknowledges that PV-10 worked and that it reduced or eliminated from 1 to 10 melanoma lesions per patient.
    I reiterate, these quotes from the FDA Letter means the FDA said the drug worked, people.

    REGRETTABLY

    They also said they were not granting BTD because eliminating tumors is not the kind of data they think relevant for "locally advanced cutaneous melanoma."

    Seems relevant to me and I bet it seems relevant to most of you, but it was not related to the "clinical benefit" of the drug, as defined by the FDA. I think the FDA was wrong, but I am not an MD and I don't work for the FDA. It is up to them, not to me, obviously.

    I based my expectations on the assumption that the FDA would be overjoyed to see a 71% Observed Tumor Response rate.,,and that this significant a Tumor-Response was better than competitors.
    That is why I was mistaken.

    I regret if what I considered my logical assumptions misled you. As I said in my prior article on the FDA decision, I know I am not infallible and that's why I explain my reasoning and not just provide people with a judgment.

    I hope to have more to say about what comes next, once I have the chance to study the situation and talk to the company. My view is that we may see an acceleration of the Liver Cancer trials. There are many more liver cancer sufferers because other cancers very commonly metastasize to the liver. It is often the liver cancer and not that original cancer that kills. With treating liver cancer, there are more people to help and much more revenue for Provectus or whoever buys the company.

     

    With this FDA disappointment, it seems important to keep in mind that PV-10 kills cancer and stimulates patients' immune systems to kill cancer.

     

    Disclosure: I am long PVCT.

    Stocks: PVCT
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Comments (18)
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  • MichaelJ8
    , contributor
    Comments (729) | Send Message
     
    Alan,

     

    I am in agreement with you 100%. This undoubtedly proves to me the FDA, and the government for that matter, can not be trusted at all... as if I had much trust for them anyway...

     

    I also thought a 71% response rate should have made it a no brainier considering the alternatives for people out there have.

     

    Like I said earlier, this will provide an excellent accumulation period for long term holders who can ignore the ignorant comments from bashers and shorts. I know I will buying more in the coming weeks....

     

    that being said... should PVCT management have announced a btd and brought so much attention to themselves...
    24 May 2014, 08:54 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (729) | Send Message
     
    shorts like to point out pvct cherry picked the data... just makes me want to spit...

     

    Even if they didn't use a subset of patients and "cherry picked" the data... its still millions of times better than any option out there.
    24 May 2014, 09:03 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (454) | Send Message
     
    Author’s reply » Many shorts lie without reservation.
    Whether you look at the total treated tumors and their response or look at all the patients or only the patients with all tumors treated, the results are always better than competing drugs for OR tumor-response and the number of CR (complete responses, aka the tumor disappears). And with Yervoy the competition PV-10 is far superior in safety (people have died from Yervoy) and PV-10 is cheaper.

     

    Shorts will say whatever they can make up, or distort, to create doubt and suspicion in those who have not done the due diligence that they should have. They didn't make up propaganda techniques but they are getting pretty good at using them.
    25 May 2014, 01:02 AM Reply Like
  • nicksanta
    , contributor
    Comments (311) | Send Message
     
    The FDA has very specific guidelines and each one has to be met. Period. When you look at data provided on the BTD application it sure seems like those guidelines need to be tweaked. I'm frustrated by the decision but excited to hear the next move.
    24 May 2014, 09:31 PM Reply Like
  • Professorredbag
    , contributor
    Comments (42) | Send Message
     
    Correct Nick...and IF the company had the FDA guidance we are told it had, someone at the company dropped the ball. A review of all the minutes of all the meetings over the years would determine that. The outcome insinuates the company dropped the ball. (I do dislike insinuation though.)

     

    Paragraph 2 in your article, Alan, is a bit confusing at least, I think. The full sentence is ""This determination is based on the paucity of data on endpoints indicative of clinical benefit (e.g., pain, infection, significant bleeding) and our INABILITY to determine the clinical significance of the reduction in the size in one to 10 target lesions in patients with locally advanced melanoma, who may have additional untreated cutaneous, subcutaneous, or visceral sites of disease." (Is benefit the same here as significance?) - part of the reason for their denial.

     

    There were hundreds of lesions treated and reported upon. Is the FDA picking out 1-10 that could not be determined to have clinical significance(benefit?) for some reason? What is that reason, if any? If they recognize any reduction in size, is that not clinically significant? Or is it these tumors were not monitored for bleeding, infection and other secondary/safety end-points?

     

    We, as shareholders, and the potential investor need and deserve some precise and clear information. I'm certainly not surprised this has not come from the agency but it is ultimately the company's responsibility. Hope they give it before Tuesday's open and can get back on track soon.

     

    Afterthought: Could it be the limit on the number of injections was the reason for the lack of efficacy on those 1-10 lesions? This is the type of groping for answers the LACK of clarity causes!
    25 May 2014, 04:55 AM Reply Like
  • Professorredbag
    , contributor
    Comments (42) | Send Message
     
    I have just listened to the complete update provided by Provectus conference call on the 23rd. It is clear to me that the FDA was caught up in its own state of transition from not recognizing this particular drug and it's method of administration a few years ago (up to 2011) to accepting it insofar as to suggest accepting a BTD for it (2013).

     

    The standards and guidelines have not been thoroughly examined for appropriate changes given that change. Specifically in the logic that if a tumor is injected and is completely destroyed that pain, bleeding and infection (caused directly by the drug and/or it's method of administration) are logically also relieved. This has been partially proven and will be irrefutably proven in the bridging study.

     

    It is unfortunate for the reason of any wait time for melanoma patients and any deaths that result from that wait that yet another government's bureaucratic lagging (contortions) does not serve the taxpayer and in this case also the patients who suffer.

     

    There has been and will continue to be good communication and coordination between the company and the agency. There will be quick response by the company to address the agency's concerns. Hopefully the company will take the suggestion to heart to work harder on its communication with shareholders and the public in general.

     

    THERE IS NOT AN IOTA OF DOUBT THAT THE DRUG WORKS AND WILL GET TO MARKET EVENTUALLY FOR MELANOMA AND OTHER TYPES OF CANCER!
    25 May 2014, 07:51 AM Reply Like
  • dramorgan
    , contributor
    Comments (57) | Send Message
     
    Alan, not much to say at this point except it never dawned on me that you owe any of us an apology. Thank you for all you do. I don't need this to be successful for another few years so, while not happy about the FDA's decision, it is a government agency. What really sucks is that peoples' lives are effected by slowing the availability of PV-10. Just nuts!
    25 May 2014, 07:51 AM Reply Like
  • Dennis R. Mahon
    , contributor
    Comments (444) | Send Message
     
    Agreed... no apology needed at all... not from you Alan... not from Dom. Thanks for all your research and writing... Dom too.
    25 May 2014, 11:57 AM Reply Like
  • lemmema2
    , contributor
    Comments (22) | Send Message
     
    To be honest with you I am really disappointed with mgmt. I hate to quote AF but he was right, mgmt put breakthrough on their website to mislead investors. I lost trust in these guys (mgmt), they will continue to bag their big paychecks and it will take ages that PV-10 will be even close to any kind of approval.
    I am out, GLTA
    25 May 2014, 08:12 AM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (454) | Send Message
     
    Author’s reply » Were you misled by them using that word?
    I was not.I doubt that many were and those who were probably did insufficient due diligence.
    PV-10 is a breakthrough in cancer treatment because it shrink treated tumors and stimulates a patients' immune system to attack other cancer cells that were not treated.

     

    There isn't any other comparable drug, after all.
    And FDA does not have a copyright on the word"breakthrough", which has a meaning, after all.

     

    This is a whole different topic than whether the FDA should have approved or whether Management was too confident.

     

    If the reason you are in or out is the use of that word, I find it surprising, but you are welcome to do what you think is best.
    Good luck to you.
    25 May 2014, 02:03 PM Reply Like
  • bojan.vasiljev
    , contributor
    Comments (4) | Send Message
     
    I agree with you. This was a clear attempt by a fraudulent mgmt to increase their own value but that has and will shoot back this week. I am sad because my money is invested. Had I known that that the mgmt would even think to act like this couple of months ago I would never had invested. Not even a cent, but now I am in deep and will wait and see. Discusting mgmt. :(
    26 May 2014, 10:53 AM Reply Like
  • nicksanta
    , contributor
    Comments (311) | Send Message
     
    Lemmema2 and bojan,

     

    Show me where mgmt said, "AF is right, we put breakthrough on our website to mislead investors." You can't.

     

    So how is AF right? He's not.

     

    Plain and simple. But if you want the truth, contact the company about it. In the meantime, you are being a conspiracy theorist because mgmt has not commented.

     

    I'm disappointed too, but i choose to focus on the facts, not one sided stories.
    26 May 2014, 12:42 PM Reply Like
  • bojan.vasiljev
    , contributor
    Comments (4) | Send Message
     
    Facts thag mgmt said fda told them to apply and fda says you have no value in the drug basically. Good luck and god bless us in this but i suspect these guys will be featured in American Greed in 2016.
    26 May 2014, 07:41 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (454) | Send Message
     
    Author’s reply » That is not at all what FDA said Bojan. It said that it could not approve BTD for locally advanced melanoma without pain and bleeding data, something that PVCT did not measure 4 years earlier when they did the trial when there was NO BTD program to have any rules.

     

    You need to read the article I just submitted after you go back and read the FDA letter carefully.

     

    Good luck to you. It is about helping people with cancer.
    26 May 2014, 08:29 PM Reply Like
  • bojan.vasiljev
    , contributor
    Comments (4) | Send Message
     
    If it is about helping people with cancer company should work harder and smarter. I follow our so even you a smart person must see that. The mgmt is suspicious and it is what it is. Somebody could have invested their last savings in this so its not about just cancer it's about peoples hard earned money too. Don't forget that.
    26 May 2014, 08:54 PM Reply Like
  • nicksanta
    , contributor
    Comments (311) | Send Message
     
    bojan, companies are not responsible for people and how they invest! Even if someone used their life savings, I would HOPE it was a LONG term investment in PV-10 and not a gamble on a quick win in BTD.

     

    Personally, I am one of those "life savings" investors. But I'm in this for the long haul, not for BTD. That's just a quicker means to the ultimate goal.

     

    Remember, BTD was denied. Not PV-10. So PV-10 and PVCT live on.

     

    The ASCO meeting on June 2nd will provide the next step. The drug still works. That's all that matters here. It's not about if someone gambled their life savings on BTD. That is ludicrous.

     

    Good luck to you.
    26 May 2014, 09:27 PM Reply Like
  • bojan.vasiljev
    , contributor
    Comments (4) | Send Message
     
    Of course they are not but they are not responsible for cancer patients either. Do you really think pvct is in it to save lives rather than to make money than you are dishonest. Thanks sand good luck to you as well.
    26 May 2014, 09:57 PM Reply Like
  • Alan Robert Ross
    , contributor
    Comments (454) | Send Message
     
    Author’s reply » Do Doctors work for free?
    Do you?
    Why did you buy the stock in the first place but to make money? Is it incompatible to do well while you are doing good?
    26 May 2014, 11:32 PM Reply Like
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