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The FDA cited the lack of human studies on the peptide and concerns about safety as its rationale

Studies noted improvements in serotonin and dopamine balance, crucial neurotransmitters involved in mood regulation

(iii) ethical concerns are reduced

Estimates based on peptide pharmacology research suggest perhaps 1-10% survives to reach systemic circulation, though this number represents speculation rather than measured data for BPC-157 specifically

doi:10.1016/S0021-9258(18)61530-3

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