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Gramps

09/28/16 2:32 PM

#85012 RE: stockdarockk #85011

I, of course, disagree with that entire statement. The labeling requirements were something that came up from their meetings, after the FDA opened the door to the new possibility of a 510(k) after all. If that is indeed the case, as I believe and you don't, then they would then move and only then--on what was needed for labeling. The FDA wasn't even thinking about clearing the product before and wouldn't spend a minute of time in that phase of the process. Period.
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Gramps

09/29/16 1:06 AM

#85085 RE: stockdarockk #85011

I disagree. But you have your opinion and I have mine. Simple enough. You believe BIEL is going to crash and burn and I believe BIEL will soar to new heights. Nothing personal--just darkness vs. light. I think that analogy sums it up.