Hi all,
Attached is the discussion points set for the afternoon session on Thursday.
https://www.fda.gov/media/141002/download
I draw your attention to discussion points 2a and 2b
Is someone with experience on the FDA process able to provide some background as to whether these disucssion points should be construed as negative?
Thank you
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-483
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