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Hodis E, Watson IR, Kryukov GV, Arold ST, Imielinski M, Theurillat JP, Nickerson E, Auclair D, Li L, Place C, Dicara D, Ramos AH, Lawrence MS, Cibulskis K, Sivachenko A, Voet D, Saksena G, Stransky N, Onofrio RC, Winckler W, Ardlie K, Wagle N, Wargo J, chong K, Morton DL, Stemk-Hale K, Chen G, Noble M, Meyrson M, Ladbury JE, Davies MA, Gershenwald JE, Wagner Sn, Hoon DSB, Shadendorf D, Lander ES, Gabriel SBl, Getz G, Garraway LA, Chin L

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

Conditions persisting six months or longer have established dysfunctional tissue patterns that take longer to remodel