(a) Approval 2 weeks ahead of pdufa. CBER pushing forward on their workload.
(b) Approved based on open label trial. (Downrampers always insisting we can't succeed without a double blind placebo controlled trial.)
(c) FDA actually did a press release on this one. Shows they find the continuing need for GVHD treatments to be compelling.
(d) And more evidence they find the need for GVHD treatments compelling: they had given this drug Orphan Drug Designation and Fast Track Designation.
(e) It will be a while before we are trying to treat chronic GVHD, and there is plenty of need for effective treatments, so I don't see this approval as concerning from a competitive standpoint. It is good for patients and reflects the importance of what we are trying to achieve.
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(a) Approval 2 weeks ahead of pdufa. CBER pushing forward on...
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