Commercial ReadinessCompany has built commercial infrastructure by hiring rare disease sales specialists, medical science liaisons, and field access staff to support patient starts at priority accounts, improving launch preparedness if approved.
Regulatory EngagementManagement reports productive, continuous interactions with the agency and analysts' base case expects approval via the Commissioner's priority voucher review process, implying regulatory momentum remains intact.
Surrogate Endpoint SupportManagement and analysts emphasize that consistent reductions in PPIX are an accepted surrogate endpoint and that agency agreement on this biomarker strengthens the case for accelerated approval of bitopertin.