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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

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However, immune cells (e.g., CD8 + T cells and NK cells) showed impaired effector functions, with reduced or no killing of MM cells in an in vitro flow cytometry assay, compared with patients who responded to treatment [33]