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Just No

09/09/18 4:51 PM

#150706 RE: edbi46 #150705

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.