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News Focus
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yankee55

07/20/16 7:23 PM

#80302 RE: Baha13 #80301

I think every poster here is thinking the same question! Hopefully, we will get some news soon.
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srinsocal

07/20/16 7:47 PM

#80303 RE: Baha13 #80301

The recent company communications have been posted on the bielcorp.com website and distributed to those on the company mailing list by E&E Communications. If you are not on the mailing list contact E&E and get added.

pknopick@eandecommunications.com

Tomorrow would be the earliest for any news IMO.
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PitchMan

07/20/16 8:41 PM

#80305 RE: Baha13 #80301

Spoke to someone at headquarters on Monday who said any announcement would take a couple of days (or so). Based on recent history I would expect something early next week. I hope I'm wrong and we hear tomorrow.
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GetSeriousOK

07/21/16 8:30 AM

#80319 RE: Baha13 #80301

The FDA didn't request the meeting. BIEL did.

You all know that, right? It's ALWAYS the company requesting the meeting with the FDA, and usually because the FDA told the company something they didn't like, causing the company to request a meeting for clarification.

Pretty clear to me: The FDA told BIEL "We have questions, and the pathway is de novo," and BIEL asked for the meeting.

In June and again in July.

When will BIEL tell you that the 510(k) is dead and it's going to be a de novo now? Probably in September when they have the Oxford data.

Meanwhile, Q2 financials will be out in four weeks. Better get some excuses ready. The excuses from the past three quarters are wearing thin.