The patients raised many issues the committee will have to grapple with. What we are talking about here is a drug that unequivocally works, and works very well. We have to weigh that against the risk.
More Quotes from Robert Temple:
There are a lot of drugs where it really is important that patients understand that there are therapies out there that might help them. And they may not have that information any other way.Robert Temple
There's no question with this kind of essentially lethal risk that there is going to have to be some kind of risk-management program.
Robert Temple
I think we got quite clear advice from them.
Robert Temple
We still believe that what you tell people should reflect the available data, even if you are a little more inclined to act in the face of uncertainty. We didn't find the sudden-death data very persuasive.
Robert Temple
Devastating diseases are often treated by drugs that have problems of their own. Own main concern is that people know what they are getting into here.
Robert Temple
It's a drug that's obviously important to the MS community, and the committee advised us to help get it out there. What we need to do is take into account all of the committee's recommendations, and reach our own conclusions about what various critical components of a risk-management program will have to be included. There are a number of details to be worked out, and we will have to do that very rapidly.
Robert Temple
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