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A negative vote typically results in the FDA issuing a final determination against listing, leaving the gray market as the only practical source though rejected substances can be re-nominated in future cycles or challenged in federal court

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Tesamorelin's Phase 3 trials and Sermorelin's original approval studies were built around HIV-associated lipodystrophy and pediatric growth failure, not muscle building, so their bodybuilding use rests on extrapolation rather than direct testing

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