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The Daratumumab epitope on CD38 was speculated to offer a favorable structural arrangement for hexamer formation, allowing efficient C1q docking and initiation of the classical complement pathway [57]

The Phase 2 clinical trials found it safe at all tested doses

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Fourth, while the applicant asserted that the FDA News Release (2021, April 1) encouraged manufacturers to transition to single-use, disposable devices, we noted that this FDA News Release does not specifically reference single-use, disposable cystoscopes but, rather encouraged manufacturers to transition to devices with features that eliminate the need for reprocessing and provided information to manufacturers on how to modify and validate their reprocessing instructions