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the small numbers, when you look at it using different statistical analyses you get

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different answers, then you feel even less secure, so. I think that it’s well taken.

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statistician” and then they make good statistical points. some of the examples that you

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are talking about involve monitoring over time and that’s the kind of situation where if

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you look many times you are going to find sometimes it goes the wrong direction, and

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that’s why we have to use monitoring boundaries to take that into consideration. Having

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said that though, you are correct that there have been some trials where they tried to

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repeat the trial, they thought the patients that they repeated the trial in were very similar,

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should have gotten the same results and they got different results. It does happen, and so,

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there is a limit to how confident that you can be, you know, how confident you could be,

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that’s for sure.

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the examples that you use, number one, were in the course of monitoring with multiple

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looks being taken. Some of them were examples of subgroups; subgroup results that

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were not born out when the same question was asked in a unified prospective way. So

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those are all factors that you have to think about. I think we have to remember what is

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this question about, and sensitivity for what, for better or for worse, I think the bar that

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has been set for approvability with the understanding that we may request and mandate

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additional studies for greater degrees of confidence.

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I guess I am still reassured because sometimes in a situation like that with

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DR. BURMAN: Thank you. Dr. Konstam.

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DR. KONSTAM: So, you know, I agree with Mike and John. Some of

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The bar that’s been set is an upper confidence level of 1.8. So, I guess in

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thinking about that, I mean that’s really the issue at hand, at least for the first part of our

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DR. PROSCHAN: I hate when these people start out with “I’m not a

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