Delta-Fly Pharma said it is pursuing an NDA path for radgocitabine (DFP-10917) after a Phase 3 AML trial missed its primary endpoint. The company plans to discuss with the FDA using earlier-stage efficacy signals and emerging combination data to support a potential conditional approval route. The approach highlights how companies are trying to salvage regulatory pathways by reshaping benefit arguments around subgroup signals and treatment context rather than a single primary endpoint. For AML developers, the case illustrates how post-failure regulatory conversations increasingly center on evidence packages that combine historical activity with modern combination strategies.