because I guess you can't have your cake and eat it too here. I think the FDA did a really
terrific job of explaining how they got there with regard to these different endpoint
definitions and did it without any bias based on what actually the data showed. I think
they did a very nice job of showing, of describing the pros and cons of the SMQ MACE
versus the custom MACE.
the FDA in my understanding has not had a chance to review the Duke evaluation, but
has reviewed the previous information. Is that correct?
to be really comfortable with that, we could have stopped there, but for my money, the
broader term has the value that it has more events in it. So when we get to the point of
really trying to dissect what the actual real upper boundary is here, you know, I guess you
wind up using the broader term with all it's vagaries and all it's problems and all the non
specificity to develop some reassurance about what that upper boundary is because of the
limited number of the SMQ MACE events. So, I just sort of wanted to make that point. I
The custom MACE is more specific and if we had I guess enough events
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patients, on multiple separate blood draws, are in my judgment hard to conclude or
hard cardiovascular events. Thank you.
DR. WYNE: No.
DR. BURMAN: No. Okay. Then Dr. Konstam.
DR. KONSTAM: Well I just wanted to comment on this discussion
DR. BURMAN: Thank you. I would like to point out for the record that
DR. TRAN: Yes.
DR. BURMAN: Thank you. Any other comments on that? Okay, thank
you. Then Dr. Wyne I think is next. Did you have a question?