That's not going to tell you. I think the heart of your question is that most studies are not powered to find adverse events, because they're very, very rare in the grand scheme of things. Most studies are powered to find out whether or not they work and whether or not there are some known side effects. I think that's a good question.
I would suggest that it is in fact the right role for post-market and not the role for pre-market. We are looking for a balance. I go back to many of our patients who have severe, life-threatening diseases, who are looking for some treatments here, and they will make those trade-offs between saying they don't know what all the risks are, they do know what some of the benefits are, and they are willing to move into this. We need to continue to collect that information post-market. Having a robust and early-warning kind of post-market system would help address what you need.
The question is this. If we have continual surveillance and we think about it as I think Health Canada has now, where do we draw the line in terms of saying it can now be made available and we'll continue to collect that information? It is a bit of a moving target, and I don't think that's wrong. Most of us are now looking internationally at life cycle of products, and it means ongoing collection.
I hear what you're saying, but I think it becomes a matter, then, of those kinds of judgments. I don't think we have it wrong yet, right now, in terms of where we give the approvals. I don't think we have it right in terms of how much ongoing surveillance we do and what we do with that information.