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umiak

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umiak

Re: doogdilinger post# 12352

Monday, 07/27/2015 2:29:25 PM

Monday, July 27, 2015 2:29:25 PM

Post# of 38634
Doog, based on FDA lag time and company 6-12 month estimate to submit NDA, I can understand the liberal "w/i 18 months" estimate for Rexista. W/i that 18 months it is not hard to see spring/summer of 2016. Company submits NDA Q4 or Q1 (6 to 10 months). Fast Track turnaround goal time per FDA is 60 days.



Emil Nolde

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