For 2nd BLA refiling, 31 January 2023 update used the words...

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!!!!!!!