It is my humble opinion that the video and new images that we saw is proof that clearance is on the horizon. By that, I mean we will be getting a PR in the month of June if not sooner.
Dean has said more than once that the FDA prohibited the showing of any new images as they saw this as marketing a product that hadn't gotten clearance.
If you watch Dean in that video, he looks like he's trying to keep a huge smile off his face. His confidence was just beaming. It's a very different image of him since the word came back that the FDA needed more questions answered as well as the radiologist review.