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Northwest Biotherapeutics, Inc. Message Board

  • annickawaechter annickawaechter Dec 13, 2011 3:55 PM Flag

    For once and for all

    To approve DCVax-L for GBM the FDA has agreed that only a phase I and phase II trial are necessary.
    There won't be any phase III-trial!!!

    "The Company’s lead product candidate is DCVax®-L which targets Glioblastoma Multiforme (‘‘GBM’’), the most lethal form of brain cancer. DCVax®-L has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). "

    Keep also in mind that it is VERY RARE that a small company has managed to penetrate that many clinical trial sites (+15). That means that professors and researchers don't have the slightest doubt that this vaccine is:
    a) toxic
    b) effective

    Keep also in mind that NWBO's technology is based on Nobel Prize winning dendric-science, like DNDN. The difference between DNDN and NWBO could be, and will be if FDA approved that NWBO is more effective in:
    1) delaying mortality
    2) increasing survival
    3) decreasing treatment costs
    4) decreasing toxicity

    Keep also in mind that if DCVax-L succeeds and gets approved, their patents and science will trigger other clinical trials to get approval for prostate cancer, kidney cancer, ...

    Take care,

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    • And, one more time, from the Zack's:
      "The study size has been increased from 141 to
      240 patients and is designed to enable the Company to petition the FDA for accelerated approval if the
      study generates results similar to those achieved in the two prior Phase I clinical trials."
      In other words -- we are in PIII. In my estimation, we are about 24 - 30 months out from Primary endpoint results. However, extraordinary patient response could shorten FDA reaction time, IMO. I also believe that there will be an exponential increase in enrollment as word gets around.
      Then, you'll see all kinds of clambering to get on board the prostate trial. All good.

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