A few things added to the length of the first resubmission:
- Waiting on the long-term survival data, which was an important dataset for the resubmission
- Having Dr Krause input and review of the resubmission material
There's no waiting for either of the above in this resubmission - hence, it should be much faster
Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-840
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