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The HLCS gene is located on chromosome 21q22.13 and is composed of 19 exons that generate eight alternatively spliced mRNAs, seven of which encode the same 726 amino acid protein

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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