edit #2:
Also this meeting was 'in hopes' for approval, however the main focus was the potency assays and whether the FDA is happy with CMC/assays which they are.they only want additional data, not more assays, no CMC issues, so a small win and a setback.
From the web conf its my understanding that the Type A will also discuss the potential to deliver REM-L to kids (via EAP or other means to be discussed within 45 days) so potential conditional approval during Type A.
Ann: Update on BLA for Graft Versus Host Disease, page-288
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