This is what I want to ask, then.
You say you have a terrific safety record, one of the best in the world. How do you know if there are adverse reactions when you don't have mandatory reporting of adverse reactions? Is it only when enormous problems occur and suddenly there is a class action suit? How do you know, based on some drugs?
One of the things we had talked about a while ago was mandatory reporting, which I firmly believe in. Even though it would it have been a hardship for me as a physician, I still think it's really important. How else are you going to know what's going on? Unless a crisis occurs and that flags it to you, how do you know whether there were minor things that you could add up together that may improve the device when you are regulating it for later on, or for the drug?