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Re: boston745 post# 7025

Monday, 09/26/2016 7:49:18 PM

Monday, September 26, 2016 7:49:18 PM

Post# of 41148
Yes, that's pretty much what I came up with for my timeline (there's also a chance of a 10-day administrative calendar day add). Keep in mind, FDA does not have to use their full time allotment, and considering the fact that this was submitted on 11/10/15, I would think that the FDA would only have to review the outstanding AI information. I go back to the cc where Sonny sounded very optimistic about "approval", which leads me to believe that Amedica and the FDA have already worked through most of the issues. Also, FDA has a stated goal of reducing decision time. As such, if the "labeling was submitted by 9/12, I think this week is still possible, but unlikely. I still think 10/10 to 10/25 is the most likely timeframe. I certainly hope it's sooner.
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