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Re: turks post# 6718

Thursday, 01/07/2016 3:11:49 PM

Thursday, January 07, 2016 3:11:49 PM

Post# of 16885
The notes will provide the committee and the public what the FDA is concerned about and what they would like the committee to focus on.

Based on the last ADCOM, I would expect it would be along the lines of issues, difficulties and problems associated with the actual implant and if the committee thinks what has been done as far as studies is safe, practical and something clinicians would be likely to do and patients would be willing to receive.

Also, the notes usually have a negative tone. The less so, the more bullish they are viewed.

GLTA,

Murocman
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