Quoye:"BUT we are in the dangerous situation of doing a lot of work on the potency assay only for the FDA to shrug their shoulders and say they still don't like it."
FDA does not operate on that basis, or subjective assessment. They consider evidence and respond on that basis. This is important to pay attention and weight to, as otherwise the whole process will los its credibility and will be seen as wasting time, which is not.
I am very positive about this annoucement and reasonably satisfied, but I also think it was fair criticism by FDA ... and for that I am also happy because it's not about our pocket but about ensuring sade and efficacious patient outcone.
Ann: Mesoblast Type A Meeting with FDA, page-36
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