NEWTOWN, Pa.--(BUSINESS WIRE)--Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow. The SPA provides FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and data analysis, and provides further agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
