revascularization events in a setting of a hospitalization recurrent ischemia. Perhaps that
can tease out, I don’t know what the incidence of revascularization in the database was.
The other observation would be we are looking at only first events. Obviously there are
other events that occur if the first event was non-fatal such as an MI, then a stroke, then a
CV death. So there is other ways of potentially enriching for events by looking at other
events or secondary or tertiary events.
others have told or have mentioned that very nicely, symptoms, EKG changes and/or MB
positivity or troponin positivity. If we are talking about other events and I think the
guidance allows for other events besides CV death, MI and stroke, and that is really a
recurrent myocardial ischemia or new myocardial ischemia leading to revascularization
where perhaps a CPK MB or troponin periprocedural may show myonecrosis.
cardiovascular safety at that point in time was our endpoints of acute CV events and that
event included revascularization procedures and you recall that we had 41 cases of
primary MACE on our data seg. We had approximately 60 cases of acute CV events.
So in order to perhaps maybe improve upon the events, we have excluded
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developed the troponin ANSAID. So what I am trying to say is the answer to your
question is, we would look at that elevation and not even think myocardial ischemia in
routine clinical practice nowadays.
DR. BURMAN: Does either the FDA or the Sponsor have a comment
DR. BURMAN: Any other comments? Dr. Veltri, you had a comment?
DR. VELTRI: I was commenting on the diagnose of MI, but I think
regarding that especially the issue of revascularization?
DR. WOLF: Before we submitted the NDA, our primary assessment of