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Provectus says PV-10's path to initial approval is "clear," Feuerstein differs

  • Provectus Biopharma (PVCT) fights back against Adam Feuerstein's negative article yesterday, claiming the article contains "several inaccuracies and omissions" and the "cherry picking of negative data" appears intent on implying that its long-delayed PV-10 melanoma drug is destined for failure.
  • In a separate release, PVCT said PV-10's path to initial U.S. approval is "now clear" per FDA meeting minutes, with Phase 2 data to be submitted in a formal BTD request this quarter with an FDA response expected within 60 days of receipt.
  • Feuerstein responds, saying investors should consider the BTD filing a "Hail Mary," noting that "BTD does not equal drug approval. Nowhere in today's update does Provectus confirm that FDA will allow an approval filing or actual review for approval PV-10 based on a tiny phase II study, even if BTD is granted. BTD in the absence of well-designed clinical trials demonstrating clear efficacy and safety doesn't mean much."
  • Shares gained 14% today, but it's hardly enough to make up for yesterday's 64% crash.
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Comments (24)
  • sheeple123jump
    , contributor
    Comments (340) | Send Message
     
    Investors or followers owe it to themselves to go and read PVCT management's actual response letter,,,,and not just form a judgment from only this abbreviated 'snapshot' here.
    This blip here makes it sound like Adam F has the final valid points, but management clearly shows in the letter Feuerstein's distortions , that read more like deceptions in my mind. Read the management letter and decide who is honest and who is not.
    25 Jan, 12:53 AM Reply Like
  • buckeyeyikes
    , contributor
    Comment (1) | Send Message
     
    As an investor, I read the management letter and found it pathetic. They could have taken the time to lay out a clear path forward but chose not to, which means to me, that there likely is no path forward. Love to be proven wrong.
    26 Jan, 09:03 AM Reply Like
  • nicksanta
    , contributor
    Comments (245) | Send Message
     
    What is not clear? They met with the FDA in December and decided to submit a request for BTD. Now we wait. Latest we should hear is early June. That is the path. Seems clear to me.
    26 Jan, 01:33 PM Reply Like
  • pensaman
    , contributor
    Comments (210) | Send Message
     
    With negative cherry picking style AF articles to help short sellers, AF will become famous and may be known as April Fool Master. Just Google Red Bengal cancer and you will have enough articles. It is a pure threat for Big pharma except Pfizer.
    25 Jan, 05:55 PM Reply Like
  • nicksanta
    , contributor
    Comments (245) | Send Message
     
    "Nowhere in today's update does Provectus confirm that the FDA will allow an approval filing or actual review for approval." - Adam Fuerestein

     

    This comment makes no sense. Of course Provectus did not confirm this. They can't. They're not the FDA! They can and will submit a request for BTD and wait for a decision. That's all they can do.
    25 Jan, 08:23 PM Reply Like
  • Gaugamela
    , contributor
    Comments (23) | Send Message
     
    The weak hands who sold their shares due to an article like Feuerstein's are a textbook example of why most people don't make money in the market. If you can't handle it, go and buy a CD from the bank and leave the stock market to the grownups.
    25 Jan, 08:36 PM Reply Like
  • diaperdawg
    , contributor
    Comments (34) | Send Message
     
    Adam is extremely negative--- when he wants to be. On Serepta (SRPT), he's at the forefront of positive support and creating a cult status. This guy needs some contemporary journalism integrity.
    25 Jan, 10:18 PM Reply Like
  • Riv07
    , contributor
    Comments (4) | Send Message
     
    Like I have previously mentioned, Adam F. has a BA in Political Science. No where does he have any sort of medical training. He has destroyed many bio stock prices in writing of his columns. Who really knows what his motives are? He invests his money, too! Is Adam F. a "short"? Is he trying to drive down the prices of these stocks? Anyone that listens to him and Jim Cramer about bio stocks deserve to lose their money. Due your own DD! It's a shame that so many investors listen to these two about medical science. Cramer just destroyed the stock price and momentum of GALE, when he said to buy, and then turned around, a couple of days later, and said, "Sell, and take your profits".
    26 Jan, 07:46 AM Reply Like
  • eastport2007
    , contributor
    Comments (25) | Send Message
     
    Granted, having all the required parameters for a btd request, does not mean approval of the btd program's results.
    ==> But to remember, BTD programs are designed specifically for a goal to Accelerated Approval.
    ==> The program will be submitted Q1, and FDA will approve/disapprove b/4 June 1st. At least that's the goal post now.
    ==> The Request will contain all current data (?including CUP data?), and the FDA will help to quantify symptom control (Pain, infection, bleeding). FDA wants results of PV-10 injection to all lesions, cutaneous and subcutaneous. ?Will 6 months suffice for the BTD program?

     

    ==> The Data Room is still open to Big Pharma that is interested.
    ==> Asia licensing is still an open possibility w/o the BTD completion.
    ==> The share price is not a sure thing, so uplisting to NYSE/NASDAQ is only a a maybe, as positive milestonesdon't seem near-term.

     

    I have some embedded question, so if anyone has those answers or guesses, please post.
    26 Jan, 08:52 AM Reply Like
  • GlenTP
    , contributor
    Comments (8) | Send Message
     
    To me it comes down to does PV-10 kill cancer.
    According to an interview, Peter Culpepper, CFO and COO of Provectus Pharmaceuticals had with The Life Sciences Report, it does. And not only does it kill cancer, it does it every time as long as the tumors can be directly injected. (This in itself is a miracle in my mind)

     

    Here’s a quote from the interview; http://bit.ly/1591QPr

     

    “TLSR: Are there instances where a patient might be a non-responder to PV-10? Do you envision a way to determine if a patient will be a responder versus a non-responder?
    PC: Rose bengal and PV-10 are completely agnostic to tumor biomarkers. It doesn't matter if a patient is refractory or naive. It doesn't matter what type of therapy the patient is on. PV-10 responds equally, across the board, to all lesions in all patients.
    For some lesions, the morphology is such that the response does depend on lesion size. In these cases, repeat injections may be necessary. If you keep at it, you'll be able to fully ablate all the lesions you can directly access. In this regard, PV-10 is a general tool that is independent of and complementary to personalized medicine.
    26 Jan, 12:40 PM Reply Like
  • nicksanta
    , contributor
    Comments (245) | Send Message
     
    And that's the bottom line right there. It kills ever tumor it can directly access. Nobody else can say that. Nobody.

     

    Concerns with having enough data are valid. But again, if management met with the FDA and decided to go for BTD it was due to one of two possibilities:

     

    1. The FDA suggested they submit a BTD request.

     

    OR

     

    2. Management feels BTD is possible after several meetings with the FDA.
    26 Jan, 01:49 PM Reply Like
  • GlenTP
    , contributor
    Comments (8) | Send Message
     
    What’s also a really great piece of news is that Provectus no longer needs a partner, as it previously did, because it now has $18,000,000.00 on hand; http://bit.ly/1fir57I.
    26 Jan, 07:50 PM Reply Like
  • kingryan
    , contributor
    Comments (8) | Send Message
     
    Has anyone ever seen actual oncologists comment on this stock? Thats what I dont understand about pvct is everyone is so sure about it generally have no verified medical training...they are just so sure that it cures cancer yet the path pvct and the fda have planned (based on time between trials and trial enrollment) dont paint the picture of a Solid tumer cancer pancea. Cancer is one of the hardest diseases to develop medicine for hands down and this is a very unique medication making it even more speculitve molecule. I want to make people aware that if you dont understand the pharmacology (which I dont think anyone can claim they really do with this med as its novel) then look at the evidence of the progression of the drug. Does it look its treated like a cancer pancea would be? I would say no. All of this is not to say it doesn't have value or that AF timing wasnt circumspect or it won't be approved at some point for something. Just realize its very speculative . if someone is saying '' I dont understand why it even needs a phase 3'' they should get out of the stock iimmedialy because they dont understand what they are involved it and probly have way too much money in it.
    26 Jan, 07:50 PM Reply Like
  • still hoping
    , contributor
    Comments (2) | Send Message
     
    I have been "vested in/investing in" this stock for 15 years. I myself have just survived breast cancer and considered having this be the treatment backup if need be. It certainly will be my "go to" next time in that, otherwise, my only option will be full mastectomy. I, too, was set to sell but had to wait a day for technical reasons...you know the rest of the story. Our net worth dropped about $4MM pretax...This stock assures that I can retire without worry. I still can retire, without it, but worlds of difference, so I continue to work and hope:

     

    However, to say oncologists or others have not commented, fails to acknowledge that those in the professions cannot make statements, comments, outside their professional sphere of work because of the multiple insurance risks involved.

     

    That is not to say that with 5 minutes effort, one cannot find an overwhelming trail of medical professionals who have both tested and reported on the product. You can see the progression on this through the years and the flurry of findings in the last several months.

     

    I would think that the Moffitt Cancer Research Center could be considered reputable medical/cancer evaluator.

     

    Have you not seen the report: accessed through link below:

     

    http://bit.ly/1bsd4Sb

     

    I excerpt the notes:
    Funding: This work was supported by a sponsored research agreement from Provectus Inc. to the H Lee Moffitt Cancer Center and Research Institute. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

     

    and extract a portion of the abstract:

     

    "These studies establish that IL PV-10 therapy induces tumor-specific T cell-mediated immunity in multiple histologic subtypes and support the concept of combining IL PV10 with immunotherapy for advanced malignancies"

     

    and there are multiple data points.

     

    Further if you go to:

     

    http://bit.ly/1bsd4Sc

     

    You will see dozens of peer reviewed articles, presentations, white papers, and there are multiple trained medical experts that have participated in all this....(Oncologists, researchers, and clinical trial information medical specialists, oh my!-I apologize, I could not resist.)

     

    Though I have to go back to work, just look at some of this and see if this addresses your comment.

     

    Moffitt has issued various press releases, but one you can validate at :

     

    http://bit.ly/1dSywp5

     

    And please read what they say herein:

     

    Press Releases | 2013

     

    Where You Are:
    Home > Press Releases > 2013

     

    Single Injection May Revolutionize Melanoma Treatment, Moffitt Study Shows

     

    Aug 22, 2013

     

    TAMPA, Fla. – A new study at Moffitt Cancer Center could offer hope to people with melanoma, the deadliest form of skin cancer. Researchers are investigating whether an injectable known as PV-10 can shrink tumors and reduce the spread of cancer. PV-10 is a solution developed from Rose Bengal, a water-soluble dye commonly used to stain damaged cells in the eye. Early clinical trials show PV-10 can boost immune response in melanoma tumors, as well as the blood stream.

     

    “Various injection therapies for melanoma have been examined over the past 40 years, but few have shown the promising results we are seeing with PV-10,” said Shari Pilon-Thomas, Ph.D., assistant member of Moffitt’s Immunology Program.

     

    In the initial study, researchers injected a single dose of PV-10 into mice with melanoma. The result was a significant reduction in the skin cancer lesions, as well as a sizable reduction in melanoma tumors that had spread to the lungs. The researchers said the dye solution appeared to produce a robust anti-tumor immune response and may be safer than existing immunological agents.

     

    “We are currently in the middle of our first human clinical trial of PV-10 for advanced melanoma patients. In addition to monitoring the response of injected melanoma tumors, we are also measuring the boost in the anti-tumor immune cells of patients after injection,” explained Amod A. Sarnaik, M.D., assistant member of Moffitt’s Cutaneous Oncology Program.

     

    The initial study appears in PLOS ONE, an open-access, peer-reviewed online journal. It was supported by a sponsored research agreement with Provectus Pharmaceuticals, Inc., developer of PV-10.

     

    About Moffitt Cancer Center
    Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Since 1999, Moffitt has been listed in U.S. News & World Report as one of “America’s Best Hospitals” for cancer. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. For more information, visit MOFFITT.org, and follow the Moffitt momentum on Facebook, twitter and YouTube.

     

    5 Feb, 08:19 PM Reply Like
  • User 16974452
    , contributor
    Comment (1) | Send Message
     
    Rumors says that a Chinese Biotech investor, is preparing an offer at $1.8B market cap before submitting the BTD request. Can anyone confirm the rumors?
    27 Jan, 08:02 AM Reply Like
  • 15985972
    , contributor
    Comments (5) | Send Message
     
    The stock majority of the stock is in the hands of European aristocrat families. The Chinese can come with any offer he wants and he is welcomed but nothing will be looked at or endorsed or signed off below $30 a share. Doing an acquisition based on melanoma valuation only for a Liver market off label use is clever...but we won't be fooled. We own it and want to see approval for melanoma + approval for liver. Then we can talk.
    28 Jan, 11:14 AM Reply Like
  • 15985972
    , contributor
    Comments (5) | Send Message
     
    The stock majority of the stock is in the hands of European aristocrat families. The Chinese can come with any offer he wants and he is welcomed but nothing will be looked at or endorsed or signed off below $30 a share. Doing an acquisition based on melanoma valuation only for a Liver market off label use is clever...but we won't be fooled. We own it and want to see approval for melanoma + approval for liver. Then we will see...
    28 Jan, 11:14 AM Reply Like
  • gongik
    , contributor
    Comments (5) | Send Message
     
    Also, kingryan, and others of you, if you are looking for “the evidence of the progression of the drug and not just naïve speculations you should in fact consult the comments (though not personally written by oncologists) in other posts who have done their DD and are graciously sharing the solid data they’ve gathered from only the most renowned oncologists, who I am sure do more than just sit and speculate the potential of the medicine when they validate, and with assurance, present PV-10 as a compelling solution to tumor treatment as they do in many of these resources.

     

    Just a general note of current status of PVCT for those who are new to this other than the fundamental fact that PV-10 presents high efficacy (high response rate) and pristine safety profile (side effects treatable with Tylenol):
    1) Clear advantages over other recent BTD precedent for melanoma (higher efficacy, significantly lesser side effect, much larger sample size),
    2) Significant amount of clinical data that was submitted (including the CUP data that has been gathered over the past few years, NOT just 28 patients, who by the way experienced complete treatment, which only indicates that FDA wants to use this portion separately as a specific evidence for confirmation of the efficacy),
    3) The new indication broadens the application of PV-10 and makes it even more lucrative,
    4) BTD application is something that is advised by FDA as part of their guidance, and not something that is attempted with blind courage and “speculation,”
    5) Bridge study mentioned by PVCT which many seem to confuse as an exhausting trial of many years and dollars, is a mini study of a short duration to confirm observable efficacy of the drug (in this case, shrinking of the tumor) with a very small sample size.

     

    To me it seems there are compelling reasons to believe that a successful BTD approval is in line. You may call it speculation (in spite of all the data that support it), but to see it the other way seems to require much more of it. While skepticism is healthy and absolutely necessary, this too requires as much proof to justify. Based on the accumulating data that is being presented for PV-10 versus the groundless bashing that is taking place against it, it is quite easy to tell who is being the hopeless speculator
    27 Jan, 09:14 AM Reply Like
  • bradpitt83
    , contributor
    Comments (8) | Send Message
     
    WSJ release article about PVCT
    http://on.wsj.com/1d4KUwe
    27 Jan, 09:25 AM Reply Like
  • gongik
    , contributor
    Comments (5) | Send Message
     
    kingryan,
    First off, why should an oncologist come all the way here to comment on the efficacy/safety and PV-10’s potential as a BTD drug? They are not investors, but you and I are. The experts that you are referring to are doctors and researchers and they have their roles to play in conducting the trials testing and investigating the efficacy of the drugs in concern. You are correct that one needs to consult with what these experts have to say to ensure smarter investment and that's very much why a serious investor would seek confirmation from these experts via official journals, articles, seminars or firsthand contact with the appropriate personnel and institutes who are directly involved. A general suggestion would be that both you and any other speculative potential investors base your investment decisions on credible facts. But let’s not expect an oncologist to hand deliver his two cents via message board comments. That said, I’m sorry, but not having an oncologist comment on these posts doesn’t even remotely taint the efficacy or potential of the medicine.

     

    Secondly, your claim on “cancer being one of the hardest diseases to develop medicine” is extremely puzzling. What are you even trying saying? You almost make it sound as if developing a cancer medicine is a matter of impossibility. And according to your assertion, PVCT investors are dumb for speculating that PV-10 will be successful simply because it’s a medicine attempting to treat cancer. I wonder how you would evaluate a cancer medicine of the company you invest in. Or perhaps, you simply don’t believe in cancer medicine and not invest in such biotechs period.

     

    What’s funny is how your argument is just as bad as Adam Feuerstein’s, and it seems to possess a striking resemblance in how it attempts to instill fear with groundless pessimism, but in such righteous manner. You aimed for sounding smart and rational, but actually presented nothing of use. Only misleading assertion as if there is no data or substantial progress that is being made with the medicine. Much to the contrary to what you propose as being vitally essential, you have made this case with not even a single support from your oncological source against the efficacy and progress of PV-10. You warn us with only words, oh wait, and also with a load of speculation that people beside you are blissfully speculative of all their investment decisions.
    27 Jan, 07:37 PM Reply Like
  • nicksanta
    , contributor
    Comments (245) | Send Message
     
    SPECULATION
    - the forming of a theory or conjecture without firm evidence.
    - Medical training not required.

     

    However, there's not much left to speculate when it comes to Provectus.
    - Management has vast experience. FACT
    - Financially they are set for a Phase III, if necessary. FACT
    - Clinical trials run by well known medical professionals. FACT
    - PV-10 documented to be safe and kills a tumor almost instantly. FACT

     

    The oncologists involved with the trials have done their job. There is NOTHING speculative about the drug itself. Although AF would have everyone believe otherwise.

     

    The only "speculating" left with this company is whether or not BTD is the correct path at this time. I think it is and I base this on the FDA meeting minutes PR.

     

    That is my speculation.
    27 Jan, 09:56 PM Reply Like
  • MichaelJ8
    , contributor
    Comments (674) | Send Message
     
    AF needs to stop opening his mouth... or well, stop typing at least.
    I'm all in PVCT(well sort of, also long ONCS)
    30 Jan, 08:37 PM Reply Like
  • tonykarmen
    , contributor
    Comments (16) | Send Message
     
    i went to sleep ,it was 6 dollars woke up 2.23, who is this asshole af can we sue class action any one know , i had lotta shares since i dont know when and still do hangin in,,, u guys are informative, thanks
    31 Jan, 11:33 AM Reply Like
  • pensaman
    , contributor
    Comments (210) | Send Message
     
    Is Adam eating crow with his remarks about Mannkind?

     

    " How I Think About MannKind's Afrezza FDA Panel
    By: Adam Feuerstein | 01/10/14 - 11:37 AM EST

     

    MannKind (MNKD) will bring its inhaled, rapid-acting insulin Afrezza in front of an FDA advisory panel on April 1. [Insert April Fool's Day jokes here.]

     

    In today's Biotech Stock Mailbag, I elaborated on my prediction that FDA would reject Afrezza. That was before the FDA panel announcement, so let's discuss further."

     

    =====
    He tries to prove he is above everybody else in common sense thinking.
    Everybody please send him wrotten dead crow please..
    ============
    http://yhoo.it/1h8uESq
    FDA Panel Positive on MannKind's Afrezza
    Zacks By Zacks Equity Research
    21 hours ago

     

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    3 Apr, 01:11 PM Reply Like
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