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Ryoko

10/20/09 5:44 PM

#6161 RE: DUECE147 #6159

That's from medreports. It's just a wild guess based on average processing times for 510k's. But since each application is different, your mileage may vary with regards to how long it takes.

I think the more interesting development is the decision to do the audit now. Of course, those who have held BIEL for a while know that a full audit was promised several months ago. But as recently as a few weeks ago, Joe said the audit had been moved to the back burner and wasn't a priority. Now, out of the blue, we have an audit being conducted. So why now? Are they trying to halt the recent slide in pps? (The timing of the announcement does seem curious.) Are they just following thru on an old promise? Or were they approached by a potential buyer? Something to ponder.