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Vical Incorporated Message Board

  • onceaphilosopher onceaphilosopher Jun 28, 2011 5:20 PM Flag

    FDA Oncology Drug Approval

    http://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm103366.pdfnke

    The A-7 P3 is being conducted under a Special Protocol Assessment (SPA)

    Which means that the FDA AGREED in writing to the powering of the study for FDA approval.

    Overall Survival is MORE important than PFS!!!!

    Yervoy had ONLY 138 pts in the Yervoy only arm.

    The OS benefit of Yervoy was appx. 63% over the control arm.

    If A-7 matches that 63% OS benefit, then A-7 is guaranteed FDA approval.

    Median Survival Time is the BEST way to determine to OS.

    Vical says that it is NOT likely there will be enough death events to lock the DB and close the study by year end.

    The average and median patient has been on study for 26 months NOW....

    So, even if control group lives 14 months in median, 3 months longer than the estimate by Vical, A-7 has already demonstrated statistically significant efficacy for FDA approval.

    If you listen to Avii (GNVC loser) and Chipmunk brain, you will NOT understand the REALITY of this situation.

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    • Thanks Chip. It is either his way or the highway. I am a supporter of Vical. I am in for the long haul. I am not selling, I am going wait for the approval. I think there is a 80-85% chance A7 will be approved, and that is good enough for me.

      My reasons are the longer than usual survival; we are going to pass the OS. Also, there were a number of patients from stage 2 that did not get the full 2 cycles of treatments.

      Most of the responders got the full 2 cycles. Phase 3 was designed to ensure all persons got the full 2 cycles. There is a very high probability that A7 will be approved.

      However, there is a slight chance the "P" value could be a problem. It is basic commonsense. Ocean I asked you to send the link or links. You did not. Reason? You cannot. You are a fabricator. The board deserves an apology.

    • Chip, Wow! I never thought I'd live to see a molecular monolayer of beaten, flattened horse... Every day brings a new wonder.

      Say,.. how would you define success / fail criteria for computing a p value for OS (secondary end point) ?

    • "Docs like to talk to other Docs when it comes to medical issues.

      One of the reasons that Vical is so cheap, is because of a lack of credibility in the Oncology world.

      Oncologists rightly wonder why a company that is in a pivotal study to cure or treat cancer, does NOT have an Oncologist on staff."

      Do you know for a fact that nobody on the VICL BOD serves as the medical interface with the cancer community?

    • onceaphilosopher

      I have been an outsider reading all of your posts. You are a great pumper,and are long Vical, with a vested interest in driving up the stock's price. However I suspect that you understand the possibility of Vical passing the OS but failing the P Value, but will not admin to it. Avii has a valid point.

      Based on the late phase 2 findings, that even non responders are living longer; it is possible that the A7 drug would slow down the progression of the disease. IE stop the tumors from getting larger, and extends the life of both responders and non responders.

      Since the P Value is based on the reduction of the tumors; if A7 DRUG stops the progression of the decease keeping the tumors from getting larger extending the life of both responders and non responders, A7 can still fail because the P Value (% Reduction in tumors not achieved ) FYI. A tumor that is suppressed is not sufficient. In order to be considered successful, the tumor has to be reduced in size.

      • 1 Reply to xavierharry
      • >>>"However I suspect that you understand the possibility of Vical passing the OS but failing the P Value, but will not admin to it."<<<

        WRONG!

        You do NOT understand what "passing" the OS means in reality.

        Using the word "passing" MEANS a statistically acceptable P value!!!!

        EVERY time the FDA uses P value as a reason to NOT give approval it is because the P value was greater than .05 This was the reason given in the Gents situation.

        I have explained what is required for a statistically acceptable level by using an ACTUAL REAL example of Yervoy, which was just recently approved for MM, the same indication for Vival's A-7.

        For the umteenth time:

        The Yervoy only arm had 137 patients.

        Yervoy extended the MEDIAN SURVIVAL TIME(OS) by 63%.......

        A-7 has 260 patients in their arm.

        IF A-7 increases the MEDIAN SURVIVAL TIME by the same 63% it will ALSO produce a statistically acceptable P value.

        The greater the SURVIVAL benefit A-7 produces the greater the statistical significance!

        Are you following me?

        >>>"Since the P Value is based on the reduction of the tumors;"<<<

        WRONG!
        There is NOT just one P value!

        There is a P value for each end point.

        Those P values are independent of each other.

        Overall SURVIVAL is the GOLD standard!

        If A-7 produces statistically acceptable SURVIVAL then that is ALL that matters!

        The FDA is VERY clear about this!

        The FDA does NOT really care about tumor shrinkage!

        The FDA is ONLY interested in SURVIVAL.

        And, the QUALITY of the SURVIVAL.

    • >>>"1) Do you think the CMV vaccine is truly garbage? And has no potential? And I guess, judging by your comments, is a waste of money as well."<<<

      The Transvax vaccine is a major distraction, with a tiny market in BMT. It can NOT be used as prophylactic for women of child bearing age!

      Diluting the upside from A-7 by funding Transvax is something only Vijay the clown could dream up.

      >>>"2) I thought VICL had enough money to carry us into 2012. If so, and with an expected stock price in early 2012 of ...what would you say?...about $15-$20 or so...it would be a lot easier to raise needed funds at THAT level than at $4 level. I too would be quite upset if he went to the well before he had to."<<<

      So, the question is....? I would hope the stock would be at least in the high single digits, by early 2012 before the results.

      >>>"3) Finally, do you see anyone on the BOD providing the necessary scientific acumen that your on-staff oncologist would provide? In other words, do you truly think VICL is flying blind when it comes to these kinds of issues?"<<<

      I think you misinterpret the reason for having a respected Oncologist(with immunology training) on staff.

      The reason is to INTERFACE with medical community.

      The reason is to interface with Docs who are employed at investment firms, or are consultants to investment firms.

      Docs like to talk to other Docs when it comes to medical issues.

      One of the reasons that Vical is so cheap, is because of a lack of credibility in the Oncology world.

      Oncologists rightly wonder why a company that is in a pivotal study to cure or treat cancer, does NOT have an Oncologist on staff.

      This is common sense type stuff!!!!!

    • "I want $40/share for Vical and not $15....."

      On this we certainly agree. So here are some follow-up questions regarding your comments:

      1) Do you think the CMV vaccine is truly garbage? And has no potential? And I guess, judging by your comments, is a waste of money as well.

      2) I thought VICL had enough money to carry us into 2012. If so, and with an expected stock price in early 2012 of ...what would you say?...about $15-$20 or so...it would be a lot easier to raise needed funds at THAT level than at $4 level. I too would be quite upset if he went to the well before he had to.

      3) Finally, do you see anyone on the BOD providing the necessary scientific acumen that your on-staff oncologist would provide? In other words, do you truly think VICL is flying blind when it comes to these kinds of issues?

      Thank you.

    • >>>"I guess what I'm really getting at is.... is the worry about the CEO and management a truly valid concern or is it overblown insofar as A-7 goes? Is all the written angst about Vijay pointless?"<<<

      Chip, Since I am probably the most frequent poster of critical comments about Vijay, I will give you my 2 cents.

      If I thought that Vijay could damage the study, I would NOT be so positive.

      That said, he does make me nervous.

      I want FULL value for A-7, and I think that NOT having an Oncologist on staff is a major mistake.

      I want less dilution and NOT more.

      Vijay is so in love with his CMV transvax loser vaccine, that he is willing to NOT get an SPA when getting one is MUST have in this case.

      A higher stock price means less shares will be sold when Vijay raises more money later this year.

      I have been trying to stir the pot so that there will be less dilution and not more.

      I do NOT want the transvax garbage to be funded by Vical, because it will not make enough money to pay for itself.

      I also do NOT want anything done with A-7 as far as partnering until AFTER results.

      I want $40/share for Vical and not $15.....

      The FDA wants to approve drugs like A-7 because it shows that their partnership with industry is producing NEW life saving drugs(actual CURES) , so they can deflect negative comments about NOT approving the wasteful drugs like Avastin.

    • "We also get to hope the company doesn't face plant along the way - the technology is compelling and there will be value created around it, but the company occasionally suffers executive foot-in-mouth disease, and there ain't no treatment for that as of yet."

      Noodles,
      Thanks for the nice note (no sarcasm either). The above appears to be a concern that at least several members share.

      Here's my question to you and any reader who might care to respond:

      Let's hypothesize that Once is correct and that the A-7 trial is an absolute winner without any scientific doubt. Is there ANYTHING that management can say or do that would turn the trial into a failure? That would torpedo the stock price when it should be rocketing higher?

      As I think about it, one thing they might do is leak the results not in accordance with protocol. But would even that cause the FDA to ignore A-7?

      I guess what I'm really getting at is.... is the worry about the CEO and management a truly valid concern or is it overblown insofar as A-7 goes? Is all the written angst about Vijay pointless?

      Thanks.

    • Chip, it's been a pleasure for me too (no sarcasm this time).

      I'm just done with this subject. We've kicked this dead horse to pieces and ran it over a few times with a steam roller. Maybe a little light has been shed too?

      The result of all this expended energy (heat?!) is that we still get to wait around twiddling our thumbs, adding on dips, hoping for good news, hoping FDA continues its rational approval trend. We also get to hope the company doesn't face plant along the way - the technology is compelling and there will be value created around it, but the company occasionally suffers executive foot-in-mouth disease, and there ain't no treatment for that as of yet.

      Cheers.

    • Noodles,
      I appreciate the kind note you sent. I'll file it along with your other acerbic posts that provide all heat and no light. Rather than engage in childish displays of taunts and name-calling, the board would be better-served by frank and open discussion of "points missed". Perhaps somewhere in your background you were taught better.

      It's been a thrill working with you.

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