FDA Alignment Received on Registrational Studies Design for NDV-01 for 2L refractory high-grade NMIBC and in intermediate-risk NMIBC in the adjuvant setting
“We are very pleased with the FDA’s alignment on the registrational design for NDV-01 in high-grade BCG-unresponsive NMIBC,” said Raj S. Pruthi, MD, Chief Medical Officer – Oncology at Relmada Therapeutics. “A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives. This study represents the fastest path to approval for NDV-01.”
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