Pivotal, adaptive MIRACLE Ph 3 trial designed for possible accelerated approval of Annamycin + cytarabine for the treatment of R/R AML
“We thank the FDA’s Divisions of Hematologic Malignancies I and Cardiology and Nephrology, as well as related divisions, for a very constructive EOP1B/2 meeting and for their valuable feedback. Armed with this, we are now able to finalize plans for a pivotal approval pathway in AML,” commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “Importantly, consistent with the FDA’s recommendations, the adaptive Phase 3 trial will rely solely on CR (complete remission) at day 30 as the primary endpoint versus placebo, a standard we are confident Annamycin will meet and that provides an opportunity for accelerated approval.”
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