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
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