I think a few things are involved in the adequate testing of a drug. One is the numbers of patients tested and another is the length of time to which they're exposed to the drug during the testing process. My colleagues who do the pre-approval testing can work with me to get information on this for you. We use standards for drugs that are going to be marketed for chronic use, and we can get those to you. I think it's important to understand, though, that many of the serious adverse events are also relatively rare, and even large clinical trials won't pick up all of them. So it's a balance we have here.
On April 29th, 2008. See this statement in context.