Ann: FDA Notifies Clinical Data Sufficient for Refiling aGVHD BLA, page-865

We refile
Fda takes up to 30 days to respond if it is accepted.
If accepted they issue a PDUFA date depending on whether they deem it to be a class 1 or class 2 resubmission.
Class 1 is max two months from date we refiled- Class 2 is max 6 months from date we refiled.

First submission was a PDUFA date of 6 months.

Second was a PDUFA date of 5 months.

FDA can shorten the time frames in both classes but rarely exceed the timeline.

Class 2 will happen if the new data file submitted is enormous.

We will get a date less than 5 months. Everything else is speculation.

I figure the board will want a result prior to the annual meeting.

Reg