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no large-scale controlled trials Lack of FDA approval process No sponsor has pursued formal approval Quality concerns Peptide impurities and characterization challenges in unregulated manufacturing The economic reality: Unpatentable peptides cant justify the $50100M+ investment required for Phase 3 clinical trials, which is why BPC-157 has peer-reviewed preclinical data but no completed human trials

Because the peptide has not been extensively studied in humans, researchers do not yet fully understand its potential side effects, drug interactions, or long-term health implications

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