moving fast, page-11

Reading between the lines here - does not seem like this is a high priority for the FDA. I hope they don't just see this as going through the motions before being able to give a full and formal no!

Also fishy that management have been "surprised" so often. I hope they are not living in denial.

I also imagine it is a tough job being the FDA, as you get little praise for getting things right, but get your backside kicked a mile if you get anything wrong. Also it is not their job to hold applicants' hands - there is plenty of guidance and information as to how to make a submissions. If the submission is borderline or inadequate, then so be it.