$NMRD why is there so much confusion on the board? De novo apps take up to 120 FDA business days to approve. According to the math, there's still a month worth of business days left in that timeline. FDA updated the procedure for accepting de novo apps in 2012, and I posted a pdf snapshot of that on a previous thread. -- the company never said that approval will be in 2020. The ROLLOUT, preceded by fda approval (should it be granted) is in 2020. They have no control over the fda, so they can't even comment on expect completed review dates. Therefore, get your information on the review process from the fda. Also, the fda gives feedback in 15 days as to whether or not the submission has been accepted. Did anybody see a pr that it was rejected? That's material, and required to be released promptly. For the record, you didn't see it because it's not there. Patience fellow traders. Exercise patience. Early January should be the latest we'll be updated.