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Joint Meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee

On Wednesday, November 18, 2015, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and the Oncologic Drugs Advisory Committee (ODAC) did not support, by a vote of 6-Yes to 18-No, with no abstentions, the safety and efficacy of (BLA) 125593 for Mycobacterium phlei Cell wall-Nucleic Acid complex (MCNA), submitted by Telesta Therapeutics Inc. (Telesta). The proposed indication is treatment of non-muscle invasive bladder cancer (NMIBC) at high risk of recurrence or progression in adult patients who failed prior Bacillus Calmette-Guérin (BCG) immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing.