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Re: Don'tDrinkTheKoolAid post# 215273

Monday, 07/18/2016 12:37:02 PM

Monday, July 18, 2016 12:37:02 PM

Post# of 401110

he said just label and instructions could be all they want or worst case a BE study.

No, I don't think he gave the indication he expects label and instructions to be enough at this point. That was the original expectations. FDA probably won't allow that related labeling without an official, formal study to back it up.

We all know it's unnecessary, but the FDA will want those i's dotted, most likely, though not necessarily for legitimate reasons.
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