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".