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flipper44

11/14/16 1:47 PM

#82964 RE: Jack2479 #82963

Pardon, I meant Hopefulsurgeon with regard to rolling review comments....my apologies.

There is no indication from Les that there is a rolling review going on even though they have been back and forth with the FDA for over a year. -- Hopefulsurgeon



Again, I think Doingmybest hit the nail on the head:

"So, if Les was talking about his thoughts on approval and if he was being realistic, it sounds like he is talking about a rolling submission underway resulting in a short final submission of the P3 data and a shortened FDA review and approval period for AA. -- Doingmybest"



(Note: Your quote from Les is very much appreciated.)