Wednesday, September 30, 2020 10:57:37 AM
Which is why the failure to get it right in April/May, after a year+ of having "rolling submission" from FDA, was and is so incredibly crippling.
Get it right, PDUFA date could have been Christmas 2020.
As is, BLA has not been submitted. Then 60 more days to review by FDA.
Then (hopefully) acceptance with a PDUFA date 6-10 months out.
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