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studies I listed had initially a favorable outcome and then demonstrated--

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DR. BURMAN: I thought you got it the other way around.

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next question, which is how do these different tests help us with regard to sensitivity

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for assuring us that we are below that bar. I guess, so what is the probability that we will

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go from the point estimate that we have with this one look that was taken but multiple

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methods that were used, what is the probability that that will go all the way to being

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above a 1.8 upper confidence limit. We are not asking that we be assured that this

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actually is a beneficial drug, right, its just - how sure are we that it’s below the 1.8.

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40 events, so as were most of these. Most of these studies where they said, hey we’ve

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seen something here. It’s the under the hundred event number, and they tend to cycle

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around 40 to 50. My point in the direct response to the question was for me, as a panel

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member, it would have been helpful to actually see some different, not statistical

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several studies where there were - initial studies evaluation showed that there was a

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poorer outcome and then on the longer study, there was either neutral or better outcome.

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We discussed earlier, I just want to make sure you are not aware of any studies where

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there was no outcome or maybe even a beneficial outcome of the early studies, but over

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the longer term there was an adverse effect.

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DR. BURMAN: Thank you John. Can I follow-up? You’ve mentioned

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DR. TEERLINK: Actually, I was bringing up the list of studies. Those

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DR. TEERLINK: So, yes. The Vesnarinone trial was an excellent

example of one that was not post-hoc, it wasn’t multiple visits, it was…

DR. KONSTAM: They were multiple groups, there were multiple groups

DR. TEERLINK: It was a pre-specified look, and it was based on about at

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in that.

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