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angina, heart failure, myocardial infarction; these cardiovascular events have been used

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in this specific community. So certainly I would recommend that the current Sponsors

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look at those definitions and obtain as much of the information as possible to allow, even

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though it may be post-hoc adjudication. Also try to gear up to do as much adjudication as

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possible prior to breaking database lock and/or code break. If they still have to - if they

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are beyond that point then try to go ahead and, I think is what this Sponsor here tried to

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do, send it off to Duke. Obviously do it earlier. You folks knew this was going to be an

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issue. So give them more than four weeks to do it and as much possible information as is

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available, and try to do, you know, as close to the guidance document as possible.

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but I like the committee’s input on, besides looking at custom MACE and broad

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MACE, what else can we do? John, do you have some suggestions?

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huge problem here, which is that the drugs that have already been approved were not

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approved on the basis of long-term outcome trials. I think the idea of figuring out exactly

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what you want to compare it to, I mean, if you put someone on a background therapy that

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turns out to cause heart attacks, it may obscure any harm that the current drug, not your

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drug, causes. So I mean, ideally I think it would be best to just cancel all the approved

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drugs. I know this is not...Just cancel them all, make them do long-term placebo

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controlled trials. I know that’s not possible but...

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DR. TEERLINK: There are clearly fairly standard definitions for unstable

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DR. BURMAN: Mike.

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DR. PROSCHAN: Go back to what I said before, I think that there is a

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DR. BURMAN: That is just a modest proposal.

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DR. PROSCHAN: Now the transcript doesn’t record laughter and that’s

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going to come out like you really meant it.

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