Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and Provide the FDA with additional data supporting the selection of the optimal dosing level v ...