Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-813

For 2nd BLA refiling, 31 January 2023 update used the words "expected to be filed shortly"






Literally the next day, 1 February 2023, we received a further update confirming BLA resubmission.





If SI said during BP conference that BLA submission is "imminent", I have a feeling it may be filed in the coming week.

Once the FDA formally acknowledges receipt and assign classification (either class 1 or 2), we should get the PFUDA date.

The clock for PFUDA date starts running from FDA's "receipt date", rather than the submission date.



We're almost there.

GLTALTH!!!!!!!