FDA, are an agenda upto themselves.
there are many many avenues to get things approved quicker, and as i have said many times, if its safe and works = approvaL it is the actual mission statment of the the FDA, but then the FDA want extra and then changes what they want, and get influenced by others....all agendas away from their mission statement.
Ann: Mesoblast Type A Meeting with FDA, page-267
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