would echo the fact that a post-marketing study should include a longer trial with higher
risk patients and assessing many of the issues we discussed previously not only
cardiovascular risk and events in a codified manner. Also take high risk patients, assess
other factors such as lymphocyte count, platelet count, look at pancreatic function and
look at skin lesions potentially among some of the other issues that have been discussed.
I voted no as well because our primary goal is to protect the patient population, I just
don’t think there is enough data in the studies that have been performed thus far to be
absolutely certain that there is no risk or very little risk to many of the population studied.
longer term trial regardless of the drug, I mean I just think it’s a scary proposition
here because of the fact that the adjudication of events, there is enough uncertainty there
to make me feel even more like I do want to do a longer term trial and perhaps it would
be nice to enroll people with coronary disease, so we can get evidence on that.
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estimates are favorable, this is very encouraging, but there is a small number of events
and lack of adjudication. So I don’t think we really have enough data to be sure about
DR. FLEGAL: I also voted no for the reasons everybody stated, the point
DR. BURMAN: I voted no. I agree with the previous comments and
complement the Sponsor and the agency and the work they’ve done in trying to evaluate
this data and see if we could pull out any kind of cardiovascular safety data.
DR. WYNE: I voted no. I would like to, as people said earlier really
DR. FELNER: I voted no and mainly driven by the comments from Dr.
Teerlink and Dr. Wyne.
DR. LEVITSKY: I voted no and I agree with everyone, so I will say no