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long-term study that will evaluate cardiac risk, which seems very ill defined right now,

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well meaning but ill defined?

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nailed it exactly, the other thing I should point out too is that people need to understand

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the guidance document does not mean you have to do it; it just means this is the guidance

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we recommend that you follow to make us happy.

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on some of the advice we get and what we determine when we get together and talk

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internally about it. We now have new authorities such that if we determine that this was

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a safety issue that we had to have information on, it would be a post marketing

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requirement and under a post marketing requirement, we have great influence on exactly

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how the study will be run and we have to sign off on this, we have a lot of influence.

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DR. ROSEBRAUGH: Well, it’s, let me just tell you, it kind of depends

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document being issued. So I guess the way I am formulating this is the question to

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the panel is okay, with the data that we have in the way we have analyzed it, despite the

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fact that the guidance document was not specifically followed, does the panel feel like we

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still have that level of confidence that was expected without having specifically followed

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the directive of the guidance document, is that sort of the way you would put the

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question?

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DR. DANIELS: Dr. Daniels just following up on that last comment. We

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have a great desire to do the appropriate large outcome study after approval if possible. I

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DR. BURMAN: That’s always a good thing. Any other comments or

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DR. ROSEBRAUGH: Yeah. I think the others can weigh in. I think you

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DR. BURMAN: Thank you. Does the Sponsor have a comment?

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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questions we have, Dr. Levitsky.

DR. LEVITSKY: What will the FDA’s role be in planning this future

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