Something that the panel members need to keep in mind as Dr. Joffe mentioned in his
introductory statement is that these are programs that were all ready underway;
completed at the time the guidance was finalized. So, knowing that limitation, there is
not a whole lot you can do at this point. Going forward, the guidance clearly specifies
that there should be an attempt to enroll more patients where you can capture these events
and perhaps generalizability to the population will be to prescribe these drugs.
proceed with my thinking and I think may be the FDA can help me figure out about this.
In the guidance document, I think it very appropriately suggests that you have to do these
in high-risk patients and so you can assess the effect in its cardiovascular events. If we
get, I mean it becomes an issue of generalizability. So what kind of guidance can you
give us if we believe that the population in which the drug is studied doesn’t have
relevance to the question of cardiovascular risk? How are we to apply data from this data
set to another, to the issue of cardiovascular risk?
think what we are asking and we will want you folks to help us with during the
discussion part is whether you think having an MI in somebody that has only had
diabetes for three or four or five years, is different than an MI in somebody that has had it
for 10 or 20 or 30 years. We need your help with that, that’s part of the question.
DR. TEERLINK: Maybe I can, I am just struggling a bit with how to
DR. PARKS: I guess you’re touching on point discussion number one.
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standard of protecting the public health against these potential complications for agents
that were already in that process or how we are suppose to balance those?
DR. TEERLINK: So are you suggesting that we apply a different