DR. TRAN: Just a quick reminder; even though this is a public meeting,
please do not cross the rope and approach the panel members during breaks or anytime
rescue medication. It seems that the consensus to the panel is that this, given the
issues that we have discussed before, is an appropriate summary, and does give us
significant information regarding the risks of cardiovascular and other events in this
group. We further discussed and wondered whether there was a relationship between
rescue and a higher rate of events and it didn’t seem that that was so, and that also it
seemed the longer a patient was studied the greater the chance of risk over time. Does
that sound reasonable to the group? Then I would like to break, if the FDA has any
announcements or anything. Then we will break from 2:30 p.m. to 2:45 p.m. and
reconvene at 2:45 for the next question.
outcomes. Please discuss the adequacy of these methods for measuring sensitivity of the
results to analytical method.
No. 4 and after discussion of Question No. 4, we will move on to the voting questions.
With regard to Question No. 4, it states
like to open it up for discussion and may be ask Mike as a statistician if he would be glad
to answer part of the question.
This of course is a technical question that focuses on statistics. I would
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Question No. 4
Multiple statistical methods were used to analyze cardiovascular
during the meeting, thank you.
DR. BURMAN: Thank you Paul, I would like to move now to Question