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thinking about this and ask you if it's right or not okay. I mean and I was at that last

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panel too. So, I mean, as you say, I mean there was an attempt to sort of drive us to say

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that at the time that something comes to market there is a certain bar, there is a certain

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level of confidence that we would like to have that it does not cause cardiovascular harm.

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That bar might be high enough that you’re done or it might be at a level that it's

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approvable but more studies are needed and those were the two bars. So the guidance

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document that you generated really was in the spirit of that.

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that we know that there is a balance such that this drug will not create a great risk, and if

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we see that then they can be approved for marketing and at that point we can do a big

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long outcome study and get definitive evidence. So that’s kind of where we are at with

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this drug is to say okay, have they hit that first stage or where we can say, you know, we

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don’t see something cataclysmic here, we can let them on the market until they do their

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big long outcome study or, you know, one of our questions is even well, you know, they

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are under 1.3, what do you all think of that. So that is sort of what we need help from

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you all.

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really how you got there. So, the type of populations that you have to study and the

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approach to pre-specification and adjudication, all is there that got you to those levels of

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confidence. So now we are sort of in between with an NDA that came along prior to that

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It defined these two upper boundaries and it not only that, but it defined

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anywhere from five to seven years on top of that which could delay drugs getting out

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on the market. So they sort of had a two-stage approach.

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DR. BURMAN: Thank you. Dr. Konstam.

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DR. KONSTAM: Yeah, can I ask - let me give you my - the way I am

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They said let's try to get enough events or at least see enough events so

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