The department's interests clearly are to cover risk, no matter what the product line is. What we need to be stable about is how valid the risk is, because you don't want overreaction. So you want to really have the focus on what it should be to make sure that the risk is well managed, if there is one. So that's the study you want.
Dr. Turner was pointing to the kind of very complex analysis that has to go along, but what he's not getting now are the instruments to be able to do something effective once it's on the market, because the blunt instrument Ms. Ballantyne keeps pointing to is that we have to threaten to take it off to get more information; and it's a very old instrument.
Here you would be able to say, okay, we've identified a risk, we want to see more information, we want to see more studying to validate it. If we need quick intervention, because it's a very difficult risk to manage, then you get more direct ability to do that, including communicating well about the risk.
So what we're looking for is really being able, through the licence, to manage these various activities and make sure that you heighten the controls when you need to, and that's the life cycle governance. Once it's out there, you get the oversight that you need.