Are these real statements or @whytee interpretations?
But, let me try to go through them one by one...
"The FDA moved the goal posts" - was this in an MSB announcement? Are you sure?
"The only thing outstanding is a discussion of the specifics of the labelling" - that's from a next step perspective, after the manufacturing has been ticked off
"MSB has a collegial relationship with the FDA" - from the recent announcement, I would agree with this statement
"The ODAC voted 9-1 to approve Remestemcel" - fact! On what basis are you arguing against this?
"The potency assay is validated" - ok, maybe you can have this one - but, you are clutching pretty hard at straws
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-646
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