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Gramps

10/13/16 10:22 AM

#86284 RE: RVC #86281

"He stated that the FDA requested more clinical data, which BIEL provided this week."

Interesting the FDA is still interested in the 510(k) and asking for more clinical data----MORE, as in they have some and asking for additional. And interesting that BIEL has already provided this week. This seems to be in direct conflict with what some on this board continue to spout about there being no clinical data. Interesting.

DewmBoom

10/13/16 12:39 PM

#86296 RE: RVC #86281

Call the FDA and ask them. They have the key to the treasure.