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  • will_amd_yu will_amd_yu Apr 22, 2007 12:53 PM Flag

    Wouldn't a full approval make it impossible to complete tests?

    Wouldn't the Advisory Panel have considered this Question, and thought the better solution would be to approve it. Besides I am sure that the approval will be for LIMITED use in controlled situations and not for general use, while the research and data collection continues.

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    • Thanks guys for your helpful answers :)
      Here's another great answer convincingly arguing that the missing 35 patients for the control group could easily be enrolled outside of the U.S.:

      Does the FDA deny the approval of Provenge in order to get a more accurate reading of 9902B? Or should the FDA withold this safe and more effective treatment from ~100,000 men over the next few years until the 9902B survival data matures? I firmly believe that the agency and the company can hash out a workable solution, such as establishing a cutoff date for US enrollment, filling the remaining spots in the trial with patients from countries where Provenge won't be approved for several years (Canada, NW Europe, Australia), and approving the treatment for marketing. There is clearly an overwhelming demand in the prostate cancer community for an effective treatment like Provenge that does not have the severe side effect profile characterized by Taxotere chemotherapy.