Blinded Data InterpretationThe blinded study design limits visibility into unadjudicated events, raising the risk that early favorable trends could be misinterpreted before final adjudication.
Readout Timing UncertaintyUncertainty about when PREVAIL will reach the required event threshold increases the risk of a delayed trial readout and could postpone regulatory filing plans.
Regulatory Submission PlanningAnalysis of PREVAIL event rates may be required before meeting with the FDA, which could complicate timing decisions for an NDA submission and extend regulatory uncertainty.