BioCentury reports the FDA issued a complete response letter (CRL) to Disc, reinforcing a pattern of regulators rejecting biomarker-based approvals and raising doubts about the accelerated approval pathway’s predictability. The CRL deepens debate over the agency’s stance on surrogate endpoints and the value of newly introduced regulatory vouchers. Stakeholders are parsing the CRL for specifics on the deficiencies the FDA identified—whether analytical validation, clinical correlation, or safety concerns—to anticipate implications for similar filings. The decision adds pressure on sponsors relying on surrogate biomarkers for expedited pathways. Policy and commercial implications include potential revaluation of development plans that hinge on biomarker-driven approvals, increased regulatory dialogue on evidentiary standards, and possible downstream effects on voucher market pricing and utility.