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Bourbon_on_my_cornflakes

05/25/23 11:37 AM

#416917 RE: Anshu2 #416916

you totally made up those timelines.

At least 6-12 months after data release. It will take 2-6 months to talk to FDA (if at all), and 3-6 months to prepare an NDA.



You have no idea what the status of FDA discussion are, or for that matter how much of the NDA filing is pre-loaded and ready to go. With our three elite FDA bureaucrats, I don see why it would takk 6 months to file.