Well ,,, could have a point. The label is a very important document after all. We know the data appears sufficient for refilling, we also know that there were some remaining issues, labelling could well be those issues.
SI got the data checked before hand, would he also get the label checked before pressing the submit button. As far as I am aware the BLA would still be under the rolling review process. This would make the 2 month review more likely.
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-600
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