Simpsonly Wednesday, 05/22/19 02:03:09 PM Re: Viking_50 post# 181572 Post # of 206920 "Gottlieb the "pill pusher" is gone as head of the FDA... I feel that things have changed internally at the FDA given the hysteria behind the opioid epidemic and this administrations' push to stop addition. I'm surprisingly more optimistic now after this change to the 510(k). Let's see how this plays out.." I concur Viking and with you art. I've been involved in a few approvals and clearances in my time and your feeling that internal changes may have taken effect is a wise speculation. At the time of the 'women only' decline, I wrote of my amazement and the potential embarrassment to FDA of that position. Please read my posts 161,320, 161,932 and 161,967, if you have a few moments. I've heard that FDA staff have become very stringent on the 90 review limit and it seems to me that the withdrawal of the "Women only' 510K and the immediate submission of a replacement double-gender 510K backed up by the Neck O-A trial data may have been a workaround by Sree Koneru and FDA staff. Sort of, "I'll pull my current submission, if you'll give me a speddy review of a replacement containing new trial data." It gives FDA new data, presumably credible, from the PR, and gets everyone off the 'Women only', tangent, which should never have happened in the first place. Regardless, congrats to Sree and his team on the science side for keeping the FDA doors wide open, leaving us only with the balance of the mess . . . .