News Focus
News Focus
Followers 10
Posts 2343
Boards Moderated 0
Alias Born 04/13/2017

Re: edbi46 post# 150705

Sunday, 09/09/2018 4:51:41 PM

Sunday, September 09, 2018 4:51:41 PM

Post# of 353792
Substantive review is a step in the process

(At least that is the way I read it.)

The next step is the interactive review. In our case we want to believe that the interactive review will go something like this:

FDA calls BIEL and tells them they did a great job on their submission. Look for official statement shortly.

20% of submission were cleared within 90 days in 2016, according to that report. I believe/hope ours will follow suit. The way I see it, it could be within 60 days. But it could be longer as well.

I'm ready and waiting, checking daily if not hourly.
Volume:
Day Range:
Bid:
Ask:
Last Trade Time:
Total Trades:
  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y