Sugammedix AC unanimous approval vs FDA rejection - looked at the AC today and the story isn't quite so black and white. At the AC the FDA review material explicitly pointed out that they had yet to recieve the data from a clinical trial specifically designed to investigate the hypersensitivity issues. There was hypersensitivity data available from the earlier trials - but obviously it is possible a trial, which the AC did not see, could have trumped that data.
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