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Re: WHELANer post# 114348

Saturday, 10/14/2017 9:43:49 AM

Saturday, October 14, 2017 9:43:49 AM

Post# of 330428
More predictions on the immanent demise of BIEL. Been hearing it for the last 7 years and yet BIEL is still in business and moving closer to the finish line.

There have been lots of negative predictions about BIEL over the years:

"BIEL will go BK" ...... Wrong, Didn't Happen

"BIEL will never get FDA Clearance" ..... Wrong, 2/3/2017

"BIEL will never get OTC Clearance" ..... Wrong, 2/3/2017

"FDA will never grant BIEL Clearance with an open SEC Administrative Proceeding" .... Wrong, 2/3/2017

"BIEL does not have a Predicate Device" ..... Wrong, BIEL used 3 Predicate Devices for their successful FDA 510K Application K152432

"BIEL will have to use De Novo or PMA to gain FDA Clearance" .... Wrong, Didn't Happen

"BIEL will do a massive 1000 to 1 RS" ...... Wrong, Didn't Happen

"SEC Administrative Proceeding will halt trading" ..... Wrong, Didn't Happen

"BIEL will never be on chain store shelves" .... Wrong, Boots/Walgreens, Lloyds, Superdrug, ect

"BIEL will never partner with a major company" ..... Wrong, B.Braun

"BIEL's FDA Product Category will never be Reclassified" .... Wrong, 10/13/2015 BIEL's product category Reclassified from Class 3 to Class 2 allowing less regulation and paving the way for 510K and OTC Clearance

The reoccurring theme seems to be "Wrong".