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Eli Lilly needs to finish Phase 3 trials (mid-2026), submit a New Drug Application (late 2026), and wait for the FDA to review it (6 to 10 months)

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Indeed, in both studies, the highest frequency of TEAEs was in the normal function groups, possibly owing to the smaller sample sizes in the more severe impairment groups, or alternatively because participants with more serious health concerns, such as those with severe renal or hepatic impairment, may be less likely to notice or report mild or moderate TEAEs, as observed in populations with cancer [21]