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Re: yellow_bluff post# 14445

Friday, 09/20/2013 2:10:08 PM

Friday, September 20, 2013 2:10:08 PM

Post# of 426291
Since it seems NCE designation requires an Adcom or a reason why there was no Adcom I cannot imagine there would be an NCE designation until after the coming Adcom. I guess if it comes up during that we will know it was waiting for that. If it never comes up in the meeting then it may be a case FDA will not decide until 5 years is up as I can see no other reason why a delay outside of the Adcom requirement.
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