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The efficacy of ADCC and CDC, and consequently response rates observed in GEN501 and SIRIUS trials, are directly proportional to CD38 expression levels on MM cells

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This places the compound within a broader research context involving NAD+ biology, sirtuin signaling, and methylation-dependent gene regulation

This is the central regulatory problem that full FDA approval would need to solve and it is the reason PCAC reviews for peptides like BPC-157 often hinge on available safety data rather than efficacy evidence from controlled human studies