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Re: jour_trader post# 392407

Wednesday, 12/20/2023 2:05:08 AM

Wednesday, December 20, 2023 2:05:08 AM

Post# of 401936
Yep, your right I forgot they PR the acceptance and not the submission and that the FDA gives themselves 45 days to accept it (or not). I didn't learn that until the last CC when Nasrat spelled it out. But I am going to cut myself some slack because in the prevoius CC (Q1 2024) Nasrat declared "We always issue press releases when we submit an ANDA with the FDA". Which isn't wrong, but also isn't exactly right since they don't issue a press release until 45 days afterwards when/if it is accepted, and anything being accepted of course has the potential not to be accepted.

Given Nasrat was confident we would hear back in Dec in mid-Nov, and because he declared the PDUFA date of the second needle mover will be September of 2024 I agree with the ELTP King that the acceptance should probably drop this week. I prefer it to be next week but definitely don't want it to be delayed because of an issue in the submission.

Thank you for keeping me straight.
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