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Vical Incorporated Message Board

  • fred12263 fred12263 May 18, 2013 5:30 PM Flag

    OMG Feurstein is a putz!

    How does Adam know A-7 will fail? Quote:
    "let's assume allovectin was prolonging survival but control patients were only living 11-14 months. If that were true, the study would have likely been stopped early already for efficacy. it would not be ethical to allow control patients to continue in a study where allovectin so greatly improves survival. This has not happened, which suggests strongly that patients in both arms are living longer than expected. This is the scenario I described in the column and makes me believe allovectin will fail."

    Vical has stated on dozens of occasions that only safety was being monitored. Everyone connected to this trial has been blinded both to efficacy and survival until both databases are locked and that won't occur until the requisite number of deaths is reached.
    This is the sloppiest due diligence imaginable from a leading biotech "expert"!

    Sentiment: Strong Buy

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    • Feuerstein gets his information that the phase III trial can be halted for efficacy from the same hedge fund idiots that have been shorting millions of shares these last few weeks.

      Sentiment: Strong Buy

    • clsamg May 20, 2013 12:44 PM Flag

      I think Adam is right. Trial will fail. Remember KERX and CLSN, events were counting much slower than anticipated and everyone was saying that was because of efficacy of the treatment. Both trials failed badly. Delay is not good news. It means trial is not designed correctly.

      • 1 Reply to clsamg
      • clsamg..3 days ago you said "insider selling is never good"..Well Shorty there has NEVER been any sales by INSIDERS at VICL. 12mm plus in buys NO sales. Wow! shorty the last 3 -4 days you have had the entire payroll crawl out from thier rock and start posting HUH? whats wrong Adam didnt get it done. With his Blah blah. Your strategy is Pathetic. Your short 7mm shares and once again. If the trial had a Problem The FDA would Shut it down. The Patients are alive, and VICL has a very valuable Pipeline. Bio-pro, your a joke. Please tell the board how much you get paid 300/month. Is that how much a deal with the DEVIL is worth?THIS IS ALL VERY BULLISH. SHORT HAS NOTHING. I mean NOTHING.

    • Actually the DSMB, by definition, was NOT blinded to the efficacy and safety of A-7 versus the control agent. The DSMB had their LAST observation in early 2012 when the DOSING of A-7 was discontinued for the last patients enrolled.

      The DSMB was NOT given the power to stop the study early.

      It does NOT matter what the DSMB thinks, they were NOT given the power to decide to end the study early, UNLESS A-7 was shown to be a safety concern relative to the chemo agent used in the control arm.

      Since A-7 was NO longer being dosed after Feb 2012, the DSMB for the study was ended at that time.

      AF is an IGNORANT little PUTZ!!!!

      • 3 Replies to viclobserver
      • From 2nd quarter conference call:

        "Howard Liang - Leerink Swann

        Okay. So if I remember correctly, there’s no interim analysis in this trial. Has there been any opportunity for the DSMB to stop the trial for – either for security or for positive efficacy?
        Vijay Samant

        It’s a data safety board. They don’t have any efficacy data, but they could have stopped it on the basis of safety if they received a stage 3 or 4 adverse event, and we’ve had I don’t know how many...
        Alan Engbring

        We’ve completed five reviewed lots safety, but it’s the safety monitoring board. There’s no...
        Vijay Samant

        And we’ll have one final review later this year which will be our final review. So, those reviews have gone well, okay."

        Vijay seems to be saying the safety analysis was based on reported stage 3 or 4 adverse events. If someone progressed and was dropped from the trial and then died a few months later from their disease I don't think that usually counts as an adverse event. If it does then the phase 2 trial had more than 100 adverse events since most eventually died.

      • are you sure because thats the million dollar question

      • From 3rd quarter 2012 conference call:

        "Howard Liang - Leerink Swann

        Got it, and then I think (inaudible) no internal lower count, efficacy, does the case that independent board….?

        Vijay Samant - President & CEO

        Only for safety, no efficacy reviews, we are finding towards the data inside the third party, and the adjudication is also blinded to the adjudicator, so now we don't have independent, I am not sitting on any piece of information that you don't know.
        Howard Liang - Leerink Swann

        But does the DSMB have any access to efficacy data or survival etc.
        Vijay Samant - President & CEO

        No, only on safety. No survival, there's no survival. We don't have access to the survival and survival data base is in the third party."

        It seems clear to me that efficacy results are only now being wrapped up by the blinded expert adjudicators and there was no way the DSMB could know the outcome while there were still subjects who remained in treatment the 2 full years until Feb 2012.

        Sentiment: Strong Buy

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