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was for developing the custom MACE. It wasn't clear to me whether this was done

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before looking at the data or whether there was some feature of the data that led to the

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development of the custom MACE, and a sort of related question maybe, is this idea of a

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reassuring point estimate, I wasn’t sure what was actually meant by that?

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CLARIFYING QUESTIONS FROM THE

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COMMITTEE TO FDA

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custom MACE endpoint and the broad SMQ MACE endpoint were both defined before

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looking at any of the data. The broad SMQ endpoint used standard SMQs for myocardial

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infarction, the central nervous system hemorrhages and infarctions and cardiovascular

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death, but there was concern when looking just at the broad SMQ MACE that some of

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the events that are included in that standard endpoint, although they could be consistent

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with an acute important cardiovascular event, they may not necessarily represent such an

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event in some patients. So to try and pair that down, three clinical reviewers came up

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with, they looked through all those preferred terms and picked out the ones that they

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DR. JOFFE: Let me speak first to those custom MACE endpoint. The

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Finally, analyses of all endpoints yielded estimates of common odds ratio less than one,

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and upper bounds for the 95% confidence interval of less than 1.8. Thank you.

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floor up now for discussion by the committee and specifically questions to any of the

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members of the FDA who presented this morning, including Dr. Joffe.

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DR. BURMAN: Thank you both very much. We would like to open the

DR. FLEGAL: I would like to understand a little better what the reason

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increased CPK. Short-term and long-term results including the followup of rescued

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subjects were consistent with the short-term results.

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The MACE results were not dependent on the statistical method used.

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