Yes this is great to re-read @dyode. thanks
Gives a great overview perspective of the journey around the contentious data needed at each long step.
Also gives you some solid assurance that MSB have done the really hards yards to satisfy the pedantic FDA here around their processes and data needs.
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- Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-478
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