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OldYeller187

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OldYeller187

Re: rafunrafun post# 183147

Monday, 03/25/2019 8:57:52 PM

Monday, March 25, 2019 8:57:52 PM

Post# of 424759
I’m a little surprised they’re pushing the envelope as much as they are, considering there’s 4 working days left to submit and hit the 1Q timeline. So maybe this means it’s taking longer than anticipated. It’s hard to say, these are complicated dossiers.

I think the anticipated approval in Dec 2019 was a mistake on JTs part, not guidance on a Feb 2019 submission date. Even if they thought they could hit Feb for sNDA submission, they would never publicly put that out there, especially when they’d already provided the end of 1Q timeline.
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