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Sunday, 06/24/2018 5:10:13 PM

Sunday, June 24, 2018 5:10:13 PM

Post# of 330192
Of course, I'm a BIEL long, and want nothing but the best for the company. But these delaying tactics by the FDA, and apparently with BIEL's collaborate is quite puzzling and disheartening. I can't imagine why BIEL is doing this, but it's kinda obvious they are doing just that! For instance, take this FDA challenge program, IMO BIEL's stature as a legitimate medical device provider is far beyond what that program is trying to accomplish. The way I interpret the aim of the grogram is to help expedite the submission and clearance process for new comers (i.e., device developers still in product development, and those just out of final developmental status, and looking to get FDA ok!). Now BIEL has been in this game for more than 10 years and the FDA has more than a perfunctory idea of what BIEL's product is all about. So, why didn't BIEL just go through the normal channels to get it's product(s) submitted for clearance? I think the normal route would have saved a lot of time, for they already have products cleared. At this juncture, for BIEL shouldn't it be pretty much a procedure of "cut & paste"? Hey! Maybe I'm off the track on this one and is allll wet, as they say, but I don't think so! Nonetheless, GO BIEL!!

GLTA!!!