Capital Efficiency And PartnerabilityA design that lowers patient enrollment needs and advances studies without awaiting a commercial partner improves capital efficiency and increases attractiveness to potential pharmaceutical collaborators or acquirers.
Clinical DifferentiationConsistent, deep responses across high-risk subgroups, including TP53-mutated patients, and signals of disease-modifying activity position the therapy as a differentiated, potentially curative option in high-risk myelodysplastic syndromes.
Regulatory StrategyShifting the primary approval endpoint to complete response with duration and using a staged program with an initial smaller study followed by a confirmatory trial may reduce regulatory uncertainty and enable structured check-ins before committing major resources.