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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

The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay

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this latter field was subsequently used as the reference for ablation experiments

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