studies I listed had initially a favorable outcome and then demonstrated--
DR. BURMAN: I thought you got it the other way around.
next question, which is how do these different tests help us with regard to sensitivity
for assuring us that we are below that bar. I guess, so what is the probability that we will
go from the point estimate that we have with this one look that was taken but multiple
methods that were used, what is the probability that that will go all the way to being
above a 1.8 upper confidence limit. We are not asking that we be assured that this
actually is a beneficial drug, right, its just - how sure are we that it’s below the 1.8.
40 events, so as were most of these. Most of these studies where they said, hey we’ve
seen something here. It’s the under the hundred event number, and they tend to cycle
around 40 to 50. My point in the direct response to the question was for me, as a panel
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
poorer outcome and then on the longer study, there was either neutral or better outcome.
We discussed earlier, I just want to make sure you are not aware of any studies where
there was no outcome or maybe even a beneficial outcome of the early studies, but over
the longer term there was an adverse effect.
DR. BURMAN: Thank you John. Can I follow-up? You’ve mentioned
DR. TEERLINK: Actually, I was bringing up the list of studies. Those
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