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Category 2 of the Bulk Substances Nominated Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act Bulk drug substances used in compounding may present significant safety risks

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AOD-9604 fits a different research profile

With FDA input pending, the companies are targeting a Phase 3 trial launch in the first half of 2026

Typical 7-12 Day Protocols Most hormone therapy and fertility treatments last 7 to 12 days

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