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Re: Dough Theory post# 7192

Friday, 10/21/2016 10:12:53 AM

Friday, October 21, 2016 10:12:53 AM

Post# of 40903
The hold up seems to be related to subgroup analysis. While I think they submitted subgroup analysis for summary indications, I believe FDA is still in the substantive review phase. That means FDA is still reviewing all the information company has submitted. FDA does not seem to go by it's guidelines in regards to timeframes.
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