Agreed. I would prefer to have the BLA submission correct and complete rather than soon. We are all impatient and invested in this process and outcome but missing the mark on the BLA due to hurrying isn't a good outcome for anyone.
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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-846
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