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Why the FDA Position Is What It Is The regulatory reasoning behind peptide category adjustments is typically a combination of: Absence of sufficient human clinical trial data to support inclusion Manufacturing and quality control standardization questions The availability of alternative therapies Pharmacovigilance considerations arising from compounding pharmacy use patterns A physician hearing not approved about a compound that has been clinically useful may understandably feel that the regulatory posture is out of step with clinical experience

Additionally, the TCGA database does not disclose whether patients are GLP-1 RA-exposed or -nave, thus future transcriptomic studies may comparatively investigate these patient populations across cancer types to further dissect immunogenomic differences