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Reassignment of Bioequivalence Reviews MANUAL of POLICIES and PROCEDURES Fda Form

Reassignment of Bioequivalence Reviews MANUAL of POLICIES and PROCEDURES Fda Form

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this product is an anti-bcma second generation CTI and uh we are proud to be the first H Institute that um prospectively treat ala amiloidosis patients with the with KT uh we presented this data before but now we update on the final results uh of the phase one study we have a phase one study of this antib car multiple Myoma but this study also enrolled the subcohort of ala amiloidosis patients and we treated 16 patients thus far very Advanced patients vast majority with the cardiac involvement including myo stage uh 3B or four uh amid patients uh with um Advanced disease heavily pre-treated cohort almost all triple refractory and um uh quite a lot of patient that were previous previously exposed to an anti-bcma agent and um we first wanted to see if this therapy is safe and um we had no treatment related death and overall manageable uh toxicity with the reasonable and known as known before and uh rates of severe CRS we had no icons in this cohort um we we saw um quite frequent uh previ

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