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Home » FDA Calls for Second Phase 3 Trial of Telesta’s Bladder Cancer Candidate
FDA Calls for Second Phase 3 Trial of Telesta’s Bladder Cancer Candidate
Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety.