long-term study that will evaluate cardiac risk, which seems very ill defined right now,
well meaning but ill defined?
nailed it exactly, the other thing I should point out too is that people need to understand
the guidance document does not mean you have to do it; it just means this is the guidance
we recommend that you follow to make us happy.
on some of the advice we get and what we determine when we get together and talk
internally about it. We now have new authorities such that if we determine that this was
a safety issue that we had to have information on, it would be a post marketing
requirement and under a post marketing requirement, we have great influence on exactly
how the study will be run and we have to sign off on this, we have a lot of influence.
DR. ROSEBRAUGH: Well, it’s, let me just tell you, it kind of depends
document being issued. So I guess the way I am formulating this is the question to
the panel is okay, with the data that we have in the way we have analyzed it, despite the
fact that the guidance document was not specifically followed, does the panel feel like we
still have that level of confidence that was expected without having specifically followed
the directive of the guidance document, is that sort of the way you would put the
DR. DANIELS: Dr. Daniels just following up on that last comment. We
have a great desire to do the appropriate large outcome study after approval if possible. I
DR. BURMAN: That’s always a good thing. Any other comments or
DR. ROSEBRAUGH: Yeah. I think the others can weigh in. I think you
DR. BURMAN: Thank you. Does the Sponsor have a comment?
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questions we have, Dr. Levitsky.
DR. LEVITSKY: What will the FDA’s role be in planning this future