There were several issues raised, and I don't think I can discuss each of them, but the first one you brought up was the question of a new indication. You felt that maybe the system would allow the new indications to be evaluated too fast.
I think what we've seen so far—and I'm talking about my experience at the international level by other agencies—is that the same level of rigour in terms of clinical trial data must be provided to the assessors. It's important also to realize that the risk management plans afterwards not only include or concern the new indication but also the older indication. So basically pharmaceutical companies must make sure they really want to have that new indication, because the ramifications are very important in terms of drug safety surveillance.