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Re: None

Friday, 05/17/2019 2:00:00 AM

Friday, May 17, 2019 2:00:00 AM

Post# of 329439
Apparently, the pattern has been set. IMHO, the FDA has no intention to give clearance for BIEL's products, anytime soon. The ole Ask-For-Additional-Info within about two weeks before the 90 day decision window expires trick, is not new for the FDA. As I recall, during BIEL's previous request for clearance, the FDA pulled the same stunt, before dropping a "Wile E. Coyote" anvil on BIEL's head, so to speak. I dare say, there is a strong chance they will do the same thing this go-round. Maybe BIEL should have given up on the FDA a long time ago. JMO! Not to say that the FDA's recalcitrant behavior is the crux of all BIEL's problems, of course, they are not. Most of BIEL's problems are caused by BIEL, itself!!

GLTA!!!