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FDA staff focused on the record in front of them: little or no useful human efficacy evidence for the exact reviewed uses, incomplete characterization of the substances, impurities and aggregation, immunogenicity, and major gaps in long-term safety
BPC-157 Body Protection Compound 157 is a peptide made from 15 amino acids derived from proteins naturally found in the stomach
GHK occurs naturally in human saliva, plasma, and urine
While BPC-157 has a strong safety record in animal studies, there are currently no long-duration, placebo-controlled human trials available to confirm its effects over months or years
The combination creates a broader regenerative environment, and the two compounds do not compete for the same receptors
