Nexcella has completed a Pre-Investigational New Drug meeting with the FDA. The subject of the Pre-IND meeting was planned NXC-201 US manufacturing and US clinical trials in AL amyloidosis and multiple myeloma. The FDA reviewed the pre-IND package submitted by Nexcella including clinical data, manufacturing plan and the phase 1b/2 study protocol synopsis for NXC-201, provided guidance and recommendations, as well as addressed Nexcella’s questions on the development plan of NXC-201 in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
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