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Injectable routes carry a particular concern for immunogenicity from peptide aggregation and impurities, and FDA noted the available certificates of analysis for AOD-9604 bulk drug substances did not consistently control for impurities, aggregates, or microbial limits

FDA therefore identified a theoretical carcinogenic concern where chronic exposure activates telomerase or extends telomeres in cells capable of malignant transformation

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Sometimes, a layer of metaplasia hides underneath a layer of new, normal tissue