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windup being a great drug, right? We don’t know that yet. The point estimate is

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extremely favourable. The upper confidence limit is extremely far away from that

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magical 1.8 number. I am given more reassurance by the SMQ MACE endpoint, which

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admittedly is fairly non-specific, but at least gives me assurance again that we are very

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far away from that 1.8. I agree with the other comments that about the labelling I think

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the Sponsor did not study patients who are at extremely high risk including a large

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percentage of patients with known atherosclerotic disease and therefore I think there

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ought to be something in the labelling to the effect that those patients, that the safety in

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that kind of population has not been investigated.

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one has to consider that. I think the spirit of the guidance was that we ought to know

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something about cardiovascular risk for these drugs and the bar was set for approvability

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at ruling out an excess risk of 1.8 with a caveat that we can ask the Sponsor to do more

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post-approval and we are going to get to that in a moment. So I think that’s a really

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important point, but I think the data as they are, with all the caveats that have been said,

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which I agree with, the lack of pre-specification, the lack of adjudication, I think are

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issues and certainly the numbers present limitations.

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confidence interval for the risk ratios/odds ratio was less than 1.3. These data involved a

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total of 11 cardiovascular events in the 24-week double blind short-term study periods

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and a total of 40 cardiovascular events in the combined short-term and long-term study

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I am very reassured by how favorable the point estimate is, this might

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Question No. 2

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For the Custom MACE endpoint, the upper bound of the two-sided 95%

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DR. BURMAN: Thank you. I think that’s everyone, good. Shall we

move to the second question? The second question and the last question is;

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