picking up on the concerns that were raised by the people who voted no on the previous
question. I certainly share those concerns when it comes to a higher level of confidence
that there could not be harm here, which I don’t think you can get there from here. I
think the number of events is far too low from that, for that. I just would say and I do
think additional trials should be directed to raising that confidence and the Sponsor ought
to be extremely excited about doing those trials, because if they believe their point
estimate, they are going to have a blockbuster drug, so we shouldn’t get any resistance on
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NDA program that will require an additional post-marketing trial(s). Discussion of that
specific question or clarification?
twelve, “Abstain” zero. We would like to go around the room maybe this time starting
on the other side.
DR. KONSTAM: Well, what is there to say? I did vote no. I think, really
periods of median 62-week exposure. Are these data adequate to conclude that post-
marketing cardiovascular safety trials are unnecessary? (Vote required)
Yes, we will read this unanimous vote into the record, “Yes” zero, “No”
DR. HENDERSON: I voted no for exactly the same reasons that were just
eloquently stated by Marvin.
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
A. If voting “No” please comment on the limitations of the completed
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.