There is no new clinical data (maybe real world evidence that we aren't privy to) which is what MSB said it would gather the previous two CRLs.
Maybe the FDA has changed its mind, which would be great for MSB.
None of that is wrong, it's the truth.
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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-93
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