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srinsocal

12/28/15 7:38 PM

#67920 RE: askjsell #67916

In AW's 11/4 interview, minute 4:00, he stated that the 510k was in "Excellent condition" and "End of year we should have market clearance". If you have a more recent quote from BIEL's CEO please provide it with the source as I am not aware of one.

All of this "AW said this" and "AW said that" is worth bupkis if you don't have a verifiable source.

If January 2016 rolls around and there has been no FDA decision I am sure there will be an FDA status update from BIEL. Remember, this is the same FDA that had a goal of 6 months for the Reclassification and stretched it out to 18 months.