Blinded Study Data Visibility RiskThe blinded design of PREVAIL limits visibility into unadjudicated events and increases the risk of over-interpreting early trends, which could lead to volatile market reactions.
Event Accrual Affecting Filing PlansIf the necessary number of events in PREVAIL is not reached as planned, timing for an NDA submission could be impacted, increasing regulatory filing risk.
Readout Timing UncertaintyManagement's uncertainty around PREVAIL readout timing raises the risk that pivotal results could be delayed, which would affect regulatory and commercialization timelines.