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Sunday, January 08, 2017 11:20:21 AM
My only reservation to your comments is in the topic of trending OS.
Is "trending" in this context a legal term of art with a specific definition which can be found in federal statutes or in the Code of Federal Regulations? Or is this, as I suspect, a term with no real definition which can therefore be shrunken or broadened according to the convenience and intent of the user?
If it is the latter, then IMHO the odds of a positive and early move by the FDA are greatly enhanced.
Thanks again for your considered input.
Good luck!
-Fritz
The more you know, the less you don't know.
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