Telesta Therapeutics Inc.'s experimental drug Mycobacterium phlei cell wall-nucleic acid complex (MCNA) won't get its chance to potentially change the landscape of bladder cancer – or at least, not any time soon – if the FDA takes the advice of its advisory panel, which refused to back the marketing of the medicine for the indication the firm is seeking.
The drug, a novel, microbiologically-derived, antineoplastic agent with immune-stimulant and direct anti-cancer activity, was studied in the wrong population, said the members of the FDA's Cellular, Tissue and Gene Therapies (CTGTAC) and
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