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janice2chase

05/13/11 9:39 AM

#14179 RE: uksausage #14178

Just wondering.....Shouldn't we be hearing something from the FDA about the Recovery RX?
I believe the FDA has 60 days to either request additional info or make a decision. I remember reading that Biel needed to remove something from the application according to Andy's phone conversation with the FDA and that would have granted an approval but the FDA did not honor what they said and asked for more data.( I can't find it though )

On Tuesday, March 15, 2011, we filed our response letter to the FDA’s questions regarding our clinical studies and power level modification.

Thanks to our Chairman, Rick Staelin, Ph.D.; extensive statistical analysis, Ian Rawe, Ph.D.; medical, biology, and clinical research expertise; and Kenneth McLeod, Ph.D. Biophysics and engineering competence, we have submitted sound and complete answers.

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