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Northwest Biotherapeutics, Inc. Message Board

  • momentum2play momentum2play Mar 12, 2014 3:12 PM Flag

    Scurtiny of the German government

    he scrutiny of data appears to have included not only that for the phase 1/2 glioblastoma trials of 20 newly diagnosed GBM patients who received DCVax-L but also patients given the drug in the phase 1/2 prostate cancer and phase 1/2 ovarian cancer trials as well as patients treated with compassionate use.
    The Section 4b exemption was implemented in the German drug laws in July 2011. The approval for DCVax-L is the first such approval granted by the German regulatory authorities in multiple key ways. Only two prior approvals have been given in the more than 2-1/2 years since the law was put in place, and those were for two German companies with tissue engineered products which had already been on the market commercially under prior laws and were grandfathered for regulatory purposes, and which did not have pharmacological (i.e., drug-like) effects in the patient’s body.

    Sentiment: Strong Buy

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