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Lilly has not yet submitted for FDA approval, and industry estimates suggest a potential launch in 2028

10.1124/dmd.109.027227

FDA Finalizes Guidance on Patient-Focused Drug Development (PFDD) The new PFDD guidance reinforces that clinical trials must capture what matters most to patients symptom burden, quality of life, daily functioning, and treatment tolerability

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One Leydig-cell study gave 5 mg/kg IP every other day for three doses