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because I guess you can't have your cake and eat it too here. I think the FDA did a really

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terrific job of explaining how they got there with regard to these different endpoint

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definitions and did it without any bias based on what actually the data showed. I think

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they did a very nice job of showing, of describing the pros and cons of the SMQ MACE

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versus the custom MACE.

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the FDA in my understanding has not had a chance to review the Duke evaluation, but

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has reviewed the previous information. Is that correct?

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to be really comfortable with that, we could have stopped there, but for my money, the

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broader term has the value that it has more events in it. So when we get to the point of

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really trying to dissect what the actual real upper boundary is here, you know, I guess you

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wind up using the broader term with all it's vagaries and all it's problems and all the non

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specificity to develop some reassurance about what that upper boundary is because of the

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limited number of the SMQ MACE events. So, I just sort of wanted to make that point. I

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The custom MACE is more specific and if we had I guess enough events

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patients, on multiple separate blood draws, are in my judgment hard to conclude or

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hard cardiovascular events. Thank you.

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DR. WYNE: No.

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DR. BURMAN: No. Okay. Then Dr. Konstam.

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DR. KONSTAM: Well I just wanted to comment on this discussion

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DR. BURMAN: Thank you. I would like to point out for the record that

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DR. TRAN: Yes.

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DR. BURMAN: Thank you. Any other comments on that? Okay, thank

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you. Then Dr. Wyne I think is next. Did you have a question?

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