InvestorsHub Logo
Followers 14
Posts 1731
Boards Moderated 0
Alias Born 04/07/2014

Re: None

Wednesday, 04/24/2019 8:23:51 AM

Wednesday, April 24, 2019 8:23:51 AM

Post# of 329439
It's clear what the FDA is doing. They wait until almost the actual due date to announce their decision on clearance, then they drop another Request for Additional Information on BIEL. As I understand it, the FDA has new leadership, or, will have it soon. But, IMO, it makes "no never mind", for the FDA has BIEL up a tree, so to speak, and they are no going to relent, apparently. Thus, the "Thwart BIEL Doctrine" is living deep in the bowels of the FDA. IMO, this is a clear tactic of attrition. Of course, BIEL has no money for lobbyists to feed palms, so it's essential that BIEL has friends on the highest plateaus in government to assist them with get this done. But apparently, they don't have those bases covered either. It's your politics BIEL, or the lack of it!! As I stated in one of my earlier posts, if BIEL doesn't get clearance within 90 days of 510(k) submission, they won't get it at all. Unfortunately, it appears this situation is headed in that direction. Sad!! Real Sad!!

GLTA!!!