I wonder if there was any chance for the FDA to inspect a few primary manufacturing processes for REX-L whilst they are reviewing REM-L for GVHD. If so, it may direct the CHF and CLBP future manufacturing inspection prior to approval to desktop rather than on-site. Would also gives additional confirmation to MSB endeavours.
Ann: FDA Schedules GvHD Pre-License Manufacturing Inspection, page-249
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