Commercial And Investor UncertaintyKeeping the same number of events with fewer total patients increases variability in the confirmatory timeline, heightening uncertainty around commercial rollout and investor expectations.
Confirmatory Trial DurationReducing confirmatory study enrollment while retaining the same event requirement implies the confirmatory analysis will take longer, extending the time to final approval.
Regulatory Outcome RiskRelying on a surrogate eGFR threshold for accelerated approval creates a binary regulatory risk if the trial does not meet the required surrogate endpoint.