Saturday, November 25, 2023 10:08:52 AM
One thing that he mentioned during call made me wonder if we will get first to file for oxy or just be among the first. On flip side Nasrat also clarified GDUFA estimated dates for all, except oxy. FDA hasn’t reached out for our oxy filing yet and if we had a Q1 GDUFA I would think FDA would be all over it. I’m not sure the partial filing bought us any favorable timing. Would be nice, but this may not have any financial impact until late calendar year 2024/early 2025.
Anyone pick up on clear GDUFA date guidance for oxy?
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