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Dendreon Anonim Ortaklik Message Board

  • dinepat203 dinepat203 Jun 10, 2013 12:45 PM Flag

    Whom DNDN partner with in Europe this month?

    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, we have filed our application with the EMA as Provenge is an autologous cellular therapy requires review by both the Community for Advanced Therapies or CAT. In addition, the Committee for Medicinal Products for Human Use, or CHMP, we will be participating in an oral explanation with the CAT, mid-year. We have recently learned that for procedural reasons a possible subsequent oral explanation with CHMP would not occur for a month or two after the CAT oral explanation. We therefore now anticipate a regulatory decision in the second-half of 2013. 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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    • Continued focus on expanding clinical data: ◦ Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) continues to provide important insights into the treatment of advanced prostate cancer with PROVENGE, particularly as it relates to investigational uses of PROVENGE in combination or sequenced with other treatments
      ◦ Actively evaluating partnering strategies for European expansion; continuing to enroll patients in the sipuleucel-T European Union open-label study; expect a mid-2013 regulatory decision in Europe

      • 1 Reply to dinepat203
      • Remember Data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) continues to provide important insights into the treatment of advanced prostate cancer with PROVENGE, particularly as it relates to investigational uses of PROVENGE in combination or sequenced with other treatments

        Actively evaluating partnering strategies for European expansion; continuing to enroll patients in the sipuleucel-T European Union open-label study; expect a mid-2013 regulatory decision in Europe

        PROVENGE® (sipuleucel-T) Data Presented at An Annual Scientific Urology Meeting
        Updated May 6th 2013 3:20PM
        Three Presentations Inform the Use of PROVENGE in the Metastatic Castrate-Resistant Prostate Cancer Treatment Continuum