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Scenario 1: Priority Review Granted (Q3 2027) BLA submitted: Q1 2027 FDA accepts filing: ~2 months later Priority review: ~6 months from acceptance PDUFA date / approval: Q3 2027 Launch: Q4 2027 Scenario 2: Standard Review (Most Likely Q1Q2 2028) BLA submitted: Q1 2027 FDA accepts filing: ~2 months later Standard review: 1012 months from acceptance PDUFA date / approval: Q1Q2 2028 Launch: Q2Q3 2028 Scenario 3: Complete Response Letter or Delays (Late 2028 or Beyond) Potential causes: an unexpected safety signal emerging during review, manufacturing or facility inspection issues, or the FDA requesting additional data via a Complete Response Letter
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