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picking up on the concerns that were raised by the people who voted no on the previous

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question. I certainly share those concerns when it comes to a higher level of confidence

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that there could not be harm here, which I don’t think you can get there from here. I

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think the number of events is far too low from that, for that. I just would say and I do

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think additional trials should be directed to raising that confidence and the Sponsor ought

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to be extremely excited about doing those trials, because if they believe their point

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estimate, they are going to have a blockbuster drug, so we shouldn’t get any resistance on

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that.

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

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NDA program that will require an additional post-marketing trial(s). Discussion of that

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specific question or clarification?

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twelve, “Abstain” zero. We would like to go around the room maybe this time starting

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on the other side.

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DR. KONSTAM: Well, what is there to say? I did vote no. I think, really

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periods of median 62-week exposure. Are these data adequate to conclude that post-

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marketing cardiovascular safety trials are unnecessary? (Vote required)

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(Voting)

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Yes, we will read this unanimous vote into the record, “Yes” zero, “No”

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DR. HENDERSON: I voted no for exactly the same reasons that were just

eloquently stated by Marvin.

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DR. PROSCHAN: I voted no. Yeah, I worry about, first of all, I worry

about not doing the long-term trial and then approving a drug and not requiring any

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A. If voting “No” please comment on the limitations of the completed

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DR. BURMAN: I think we are ready to vote. So please vote on Question

No. 2, which is on the board in front of you.

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