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Re: GuTA post# 171748

Tuesday, 11/10/2015 11:51:48 AM

Tuesday, November 10, 2015 11:51:48 AM

Post# of 401800
NR said we will not hear about an NDA submission when they submit the application - they will only tell us when the FDA has accepted the submission for review which clearly will not be until 2016 - and the mode of communication will most likely be in a release - not a CC - just to clarify for y'all. He mentioned the 1st or second week of January for NDA submission. Max
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