Does the IDMC review the blinded data? I am guessing this has no impact on FDA approval pathway but is a significant derisking event for SHs and patients to continue on the trial.
I am not sure if it is standard practice in other phase 3 trials to have an IDMC or Safety Review Committees (SRCs) but it is definitely better or best practice.
Do we expect an IDMC review before the interim readouts in August?
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