Relmada Announces FDA Feedback Supporting 2 Separate Acceptable Registrational Study Paths for NDV-01 in Non-muscle Invasive Bladder Cancer

Announces NDV-01 9-Month Follow-up Safety and Efficacy Data in NMIBC FDA feedback supports 2 potential registrational trials – 1) a registrational trial in 2nd line refractory BCG-unresponsive NMIBC, and 2) a randomized controlled trial in intermediate-risk NMIBC. FDA Feedback also confirms no additional non-clinical studies are required. 9-month follow-up for NDV-01 showed a 92% overall response rate at any time in non-muscle invasive bladder cancer, with good overall safety CORAL GABLES, Fla., Nov. 04, 2 ...