thinking about this and ask you if it's right or not okay. I mean and I was at that last
panel too. So, I mean, as you say, I mean there was an attempt to sort of drive us to say
that at the time that something comes to market there is a certain bar, there is a certain
level of confidence that we would like to have that it does not cause cardiovascular harm.
That bar might be high enough that you’re done or it might be at a level that it's
approvable but more studies are needed and those were the two bars. So the guidance
document that you generated really was in the spirit of that.
that we know that there is a balance such that this drug will not create a great risk, and if
we see that then they can be approved for marketing and at that point we can do a big
long outcome study and get definitive evidence. So that’s kind of where we are at with
this drug is to say okay, have they hit that first stage or where we can say, you know, we
don’t see something cataclysmic here, we can let them on the market until they do their
big long outcome study or, you know, one of our questions is even well, you know, they
are under 1.3, what do you all think of that. So that is sort of what we need help from
really how you got there. So, the type of populations that you have to study and the
approach to pre-specification and adjudication, all is there that got you to those levels of
confidence. So now we are sort of in between with an NDA that came along prior to that
It defined these two upper boundaries and it not only that, but it defined
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anywhere from five to seven years on top of that which could delay drugs getting out
on the market. So they sort of had a two-stage approach.
DR. BURMAN: Thank you. Dr. Konstam.
DR. KONSTAM: Yeah, can I ask - let me give you my - the way I am
They said let's try to get enough events or at least see enough events so