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Eli Lilly must first compile a comprehensive New Drug Application containing all Phase 1, 2, and 3 trial data, manufacturing specifications, proposed labeling, and safety analyses

Both: Dose, route, and duration matter

Make sure all requirements are addressed to prevent unnecessary denials and delays

The composite primary endpoint occurred in 6.5% of patients in the semaglutide group versus 8.0% of patients in the placebo group (hazard ratio [HR] = 0.80

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