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FDA Submission Timeline Based on the TRIUMPH-4 success and expected 2026 readouts, analysts predict: Late 2026: Completion of core TRIUMPH trials Q4 2026 or Q1 2027: New Drug Application (NDA) submission to FDA Mid to Late 2027: Potential FDA approval Early 2028: Commercial launch Eli Lilly has not officially confirmed these timelines, but the company has indicated it will submit for regulatory approval once sufficient Phase 3 data is available
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