RE:RE:RE:Reminder: We are not AloneHi Bepando,
my understanding is that there will be no conditional approval for the original date of April 14, 2018 and that, as you stated, it will take PLI until Q4 to finish and submit new batches/data. We still have no new PDUFA date, the earliest is Q4 but most likely Q1, 2019.
I also do not understand why, they pre-empted a final communication rather than possibly obtain a partial decision. Perhaps I am misinterpreting the NR. I hope I am and that FDA will give us some positive feedback tomorrow, which is also odd…on a Saturday!
But what do I know...