Saturday, July 23, 2016 5:04:15 PM
A de novo application adds months to the clearance timeline.
A lot of bad things could happen in those months, like SEC action, a couple more quarters of disappointing revenues, and/or a reverse split.
Furthermore: none of the UK back pain studies are double-blinded controlled studies. Yes, the FDA agreed to look at them, but the FDA doesn't put much weight in testimonials and surveys.
BIEL needs the Oxford data to get the de novo cleared, IMO. I think that's exactly what Andy was saying in his radio interview.
Again -- I'm not LOOKING for negative things about BIEL. I see them, though. BIG difference.
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