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Post# of 425263
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OldYeller187

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OldYeller187

Re: HDGabor post# 183153

Monday, 03/25/2019 8:35:34 PM

Monday, March 25, 2019 8:35:34 PM

Post# of 425263
You’re right, I was applying original NDA timelines to the sNDA review, which is 2 months shorter.. My bad, got them crossed up.

It still doesn’t change the fact that the sNDA timeline never changed. JT saying anticipated approval in late 2019 was simply a slip up. He should’ve said Jan 2020 as that would’ve represented worst case (most conservative) scenario, assuming a submission by end of 1Q and standard review.

Nothing to see here, move along...

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