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guidance although I know there has been some statistical discussions about this, is that if

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you just focus on the upper bound of the 95% confidence interval and you don’t take into

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account the rest of the confidence interval and where the point estimate falls, which is our

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best guess of what the treatment is effected based on that sample data that you may be

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missing something and so, for example the guidance says an example that if a point

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estimate was 1.5, even if your upper bound was 1.8 and your lower bound was above 1,

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that wouldn’t be as reassuring as if your point estimate fell around unity with the upper

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bound of 1.8.

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events occurred in the clinical programs and those were the analyses that FDA requested

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of the company. For this reassuring point estimate to prevent myself from getting into

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trouble with the statisticians, I'll ask them perhaps to - if they have a comment on that.

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DR. JOFFE: Close to one.

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DR. FLEGAL: Close to one, but no specific definition?

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thought would most likely represent an acute important cardiovascular event as

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reported by the investigator.

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DR. FLEGAL: Yes, the guidance uses the term reassuring point estimate.

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DR. JOFFE: Maybe I will start speaking about that. The point with the

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have upper bound of 1.3 with a reassuring point estimate, then a post marketing trial

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would generally not be necessary. So in that context, the reassuring point estimate would

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be something below one I suppose would be reassuring, about...

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Now that was done just looking at preferred terms without knowing what

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DR. FLEGAL: Can I follow up on that because the slide says that if you

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DR. MELE: I’m not quite sure at what point in time we said reassuring

the point estimate. Was it in Hilton’s presentation?

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