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Alias Born 12/11/2017

Re: Novo311 post# 7979

Monday, 12/18/2017 8:09:32 PM

Monday, December 18, 2017 8:09:32 PM

Post# of 10350
I suspect there may have been a little "off the record", but until Norchi gets the FDA response in writing, we'll just have to guess.

Dr KSS said in his article that the three areas the requests did not involve were AC5 being a device, the facts and data contained within the large biocompatibility package submission, and the data from the Irish clinical trial and will not require further study.

That leaves manufacturing.