In terms of sharing information, once we've done the licensing, part of the reason that we have the focus groups is to see if the information we've provided adequately reflects the risks. Does it meet the requirements? The last time these were on the market was back in the early 1990s. As you mentioned, times have changed since then. Really, the idea is what would be the best way to share that risk information.
When we're talking about things in terms of the CDs and sharing of consent, that primarily comes from the practice community. It's the same way as clinical practice guidelines come about. It doesn't usually come from a federal regulator because of the nature of informed consent. We have no authority over informed consent and we have no authority over the practice of medicine.
So I think it's an interesting concept. I think it's an innovative approach. It will be interesting to see what comes up from the focus groups, but it isn't something we would be able to put in in terms of a condition of licensure.