As I have stated a number of times (and anyone is welcome to call the company in an attempt to refute my claim), when I spoke with Dr. Ichim on 17 July he indicated me that they had supplied the FDA with requested data. I did not ask for specifics. However, if you look at the PR's discussing the data and that it took a minimum of 14 days to generate, it was submitted (or at least en route for submission) right around that time.