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Sipuleucel-T: Active Cellular Immunotherapies and Transforming Cancer Care

Sipuleucel-T: Active Cellular Immunotherapies and Transforming Cancer Care. Chris Lockett Senior Director, Government Affairs and External Relations Dendreon Corporation. Provenge Regulatory Strategy .

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Sipuleucel-T: Active Cellular Immunotherapies and Transforming Cancer Care

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  1. Sipuleucel-T: Active Cellular Immunotherapies and Transforming Cancer Care Chris LockettSenior Director, Government Affairs and External Relations Dendreon Corporation

  2. Provenge Regulatory Strategy Basis of licensure – Improvement in Overall Survival Pivotal Study IMPACT Special Protocol Assessment FDA agreement that positive results sufficient to amend the BLA Supportive Studies D9901 and D9902A Highly favorable benefit to risk profile Submit BLA amendment by mid-November

  3. PCa Population Densities Guide Mfg Site Location NJ Facility Los Angeles Facility Atlanta Facility SDI, PCa Patient Population 2006 P.3

  4. Transforming Cancer Care • On-track to submit BLA to FDA by mid-November • Stepwise launch ensures quality, aligns with manufacturing • Early investment in NJ, Atlanta, LA facilities • Robust plans to expand ACI platform and beyond P.4

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