guidance although I know there has been some statistical discussions about this, is that if
you just focus on the upper bound of the 95% confidence interval and you don’t take into
account the rest of the confidence interval and where the point estimate falls, which is our
best guess of what the treatment is effected based on that sample data that you may be
missing something and so, for example the guidance says an example that if a point
estimate was 1.5, even if your upper bound was 1.8 and your lower bound was above 1,
that wouldn’t be as reassuring as if your point estimate fell around unity with the upper
bound of 1.8.
events occurred in the clinical programs and those were the analyses that FDA requested
of the company. For this reassuring point estimate to prevent myself from getting into
trouble with the statisticians, I'll ask them perhaps to - if they have a comment on that.
DR. JOFFE: Close to one.
DR. FLEGAL: Close to one, but no specific definition?
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thought would most likely represent an acute important cardiovascular event as
reported by the investigator.
DR. FLEGAL: Yes, the guidance uses the term reassuring point estimate.
DR. JOFFE: Maybe I will start speaking about that. The point with the
have upper bound of 1.3 with a reassuring point estimate, then a post marketing trial
would generally not be necessary. So in that context, the reassuring point estimate would
be something below one I suppose would be reassuring, about...
Now that was done just looking at preferred terms without knowing what
DR. FLEGAL: Can I follow up on that because the slide says that if you
DR. MELE: I’m not quite sure at what point in time we said reassuring
the point estimate. Was it in Hilton’s presentation?