Mr. Chair, what I can say, again, is that in our discussions on prospective language, health care professionals, among others, and patient groups brought up this issue. They raised it very profoundly with us. As a regulator, we want to have this right. It's a threshold for a very serious moment as a regulator. We did run through scenarios to make sure that the language, “serious and imminent risk”, would catch anything we could think about.
It was as rigorous an analysis as we could provide for that language.