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has not been a value in the context of other large cardiovascular outcomes trials where

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they have been prospectively evaluated for cardiovascular endpoints. If I can take a

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moment to just clarify and answer to Dr. Flegal earlier, as to how the agency came up

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with custom MACE and the broad SMQ MACE, part of it was as the applicant had

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presented that when they, I believe it was in December, you provided to us your MACE

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analysis, and the agency did ask both applicants to provide their MACE analysis and was

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a recognition that these two applications had very different approaches to providing a

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MACE analysis to us. Recognizing that if we are now holding this guidance, let's call

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them the guideposts for ruling out a cardiovascular risk, it was important that we apply

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some sort of uniform approach. That is why the custom MACE analysis the definition

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was established and applied equally to both companies.

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there are large databases of clinical outcome trials I am sure the FDA has, where there

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has been CEC adjudicated not simply investigated reported events, has there been any

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look at how predictive, what's the sensitivity and specificity of this custom MACE

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definition in those types of databases to kind of get some comfort as to how reliable,

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because it seems as though the primary MACE is done by the Sponsor and the custom

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MACE is done by the FDA, are very similar, basically point estimate and upward

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bounds?

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

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DR. PARKS: To answer your specific question, no, the custom MACE

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those events were albeit there weren't as many as for whatever reason, population,

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length of duration of followup etcetera.

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DR. BURMAN: Thank you for the explanation. Any other questions

from the Committee?

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So, a custom MACE algorithm was developed and my question is since

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