=Moleculin Biotech (MBRX)

9 August 2017:
Moleculin Biotech comments on 'several recent FDA approvals for new drugs for the treatment of acute myeloid leukemia'
Co stated, "although FDA approval of both of those drugs was based on overall survival comparisons with a standard of care, Idhifa was approved based on an accelerated clinical trial design that showed a 19% response rate in patients with relapsed or refractory AML and IDH2 mutation. What's interesting is that Idhifa was approved with a single Phase 1/2 clinical trial based on response rate, not overall survival, and a relatively low response rate at that. Also, the patient population for which it is approved represents only 13% of all AML patients. We look forward to working with FDA on a similar approach for Annamycin -- reliance on response rate in an accelerated path -- but for a larger population of AML patients."