angina, heart failure, myocardial infarction; these cardiovascular events have been used
in this specific community. So certainly I would recommend that the current Sponsors
look at those definitions and obtain as much of the information as possible to allow, even
though it may be post-hoc adjudication. Also try to gear up to do as much adjudication as
possible prior to breaking database lock and/or code break. If they still have to - if they
are beyond that point then try to go ahead and, I think is what this Sponsor here tried to
do, send it off to Duke. Obviously do it earlier. You folks knew this was going to be an
issue. So give them more than four weeks to do it and as much possible information as is
available, and try to do, you know, as close to the guidance document as possible.
but I like the committee’s input on, besides looking at custom MACE and broad
MACE, what else can we do? John, do you have some suggestions?
huge problem here, which is that the drugs that have already been approved were not
approved on the basis of long-term outcome trials. I think the idea of figuring out exactly
what you want to compare it to, I mean, if you put someone on a background therapy that
turns out to cause heart attacks, it may obscure any harm that the current drug, not your
drug, causes. So I mean, ideally I think it would be best to just cancel all the approved
drugs. I know this is not...Just cancel them all, make them do long-term placebo
controlled trials. I know that’s not possible but...
DR. TEERLINK: There are clearly fairly standard definitions for unstable
DR. BURMAN: Mike.
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.
DR. PROSCHAN: Now the transcript doesn’t record laughter and that’s
going to come out like you really meant it.