$APLT : Timeline scenarios after confusing Press Release.Best Case :
Filing Window : Nov–Dec 2025 (minutes quickly allow filing with existing dataset + agreed analyses; no new trial)
FDA acceptance (≈60 days post-filing): Jan–Feb 2026
Decision Window : Jul–Aug 2026 (priority) or Nov–Dec 2026 (standard)
Why this could happen : FDA agrees that totality of evidence (biomarkers/PROs + OLE) is file-able despite primary miss; orphan setting, unmet need.
Base case :
Filing Window :Apr–Jun 2026 (FDA asks for prespecified re-analyses, new stats plans, and more longitudinal OLE data before filing)
FDA acceptance: Jun–Aug 2026
Decision Window : Dec 2026–Jun 2027
Why this could happen : Typical after a primary-endpoint miss: extra analyses, harmonized endpoints, possibly limited new data, then file.
Worst Case :
Filing Window : 2028 (new pivotal required; 18–24 mo to run/finish + clean)
FDA acceptance (≈60 days post-filing): 2028
Decision Window : Late 2028–Mid 2029
Why this could happen :FDA concludes a new, prospectively powered study is needed given the Ph2/3 miss and prior program history.
Notes
• Acceptance occurs ~60 days after a complete NDA is submitted; the 6/10-month PDUFA clock starts at acceptance, not submission.
• Whether Priority or Standard review is granted will swing the decision window by ~4 months.
