@pfeifer1982
You wrote:
", it makes it potentially easier for the FDA to agree and not lose face regarding CRL #1 and #2, as they can claim that they led to an improved potency assay etc."
That is what I was referring to when I wrote this -
"Premises about saving face - only make sense if one supposed someone has to save face. "
I was suggesting to you, the FDA had not lost any face, so they didn't need to save any.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-539
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