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list of questions for the shholders briefing, page-2

  1. 87 Posts.
    8. Why has there been an announcement that only one patient has been recruited for phase 3 trials. Is there any problem with uptake.

    They are not going to release a new ann for every new patient.
    However I agree the process is very slow and leg behind the announced schedule, but my understanding the roadblocks are regularity and paper work.

    June 2012
    A Study Of Autologous Dendritic Cell Therapy
    Study Status
    • Approximately 1000 patients are to be
    enrolled globally to ensure 800 patients pro
    ceed to treatment.
    • In Europe 9 countries have EC approvals
    Austria, Estonia, France, Germany, Latvia,
    Lithuania , Poland, Romania, Ukraine
    Submissions to competent authorities are
    underway
    • In the US and Australia the study is approved
    and sites are undergoing site initiations.
    • 97 sites selected
    • 2 sites in the US are actively enrolling and
    one site in Australia
    • 4 patients enrolled as of May 2012
    • Complete enrollment projected for 4th
    quarter of 2013
 
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