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Dendreon Anonim Ortaklik Message Board

  • dinepat203 dinepat203 Jul 18, 2013 7:53 AM Flag


    EMA regulatory approval has the requirements like inspections of Manufacturing and supply logistics as one of the evaluation criteria which EMA looks into prior to the final approval. As a Quality Control measures these requirements needs to be fulfilled and DNDN must come out with the final plan as where Provenge would be manufactured, stored and supplied. If DNDN wants to meet the EMA deadline then time is really running out.
    CHMP - ORAL explanation requirement is now removed so manufacturing, storage and supply logistics is the next step for getting through the EMA process.

    Mark Frohlich, EVP, R&D, CMO, commented on the regulatory process for Provenge in the EU. He stated, "We also continue to make progress advancing the global market opportunity for Provenge. In Europe,
    As we have previously disclosed, we are evaluating partner strategies in Europe and continue to enroll patients in the European open label study."

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