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Ready4bluesky

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Ready4bluesky

Re: flipper44 post# 38951

Saturday, 08/22/2015 5:56:36 PM

Saturday, August 22, 2015 5:56:36 PM

Post# of 700311
Are you saying the IA would have already been submitted for EAMS, results expected prior to the conference, petition referenced in the PR refers to FDA review for AA, and the idea that EAMS approval would occur prior to FDA AA review providing another positive element for FDA consideration?
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