InvestorsHub Logo
Followers 12
Posts 2482
Boards Moderated 0
Alias Born 12/13/2009

Re: stockdarockk post# 61508

Friday, 11/06/2015 1:20:40 PM

Friday, November 06, 2015 1:20:40 PM

Post# of 334113
It started on August 6th, and ended Nov 4th. See the category change doesnt start all the 510 clocks over. The FDA works through them, and if a category or thing changes that happens outside that it might slow it down. That would work if BIEL submitted prior to Aug 6th and 91 days or more until the category change in mid Oct. Unfortunately, BIEL wasnt outside of that, and was well inside of it. Cause once the FDA was ok with the submission, they would only place the clearance in this new category. Another thing that didnt apply to BIELs submission. Sorry, its just not how the FDA works. The FDA has not been closed until mid Oct and a new category change. Categories and category control changes happen all the time.

100% agree with you on this.