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Exposure of recombinant CD38 + cells to isatuximab produced near-complete inhibition of the CD38 cyclase activity in a dose-dependent manner, while both a surrogate antibody for daratumumab (produced based on published sequences and thus potentially not completely identical to the original antibody) and daratumumab resulted in a much lower inhibition [19, 21, 22]

They claim the product is for research or not for human consumption to dodge FDA jurisdiction, Holt says