the guidance. The guidance talks about new therapies which have to go through or are
recommended to prospectively adjudicate events and include patients at increased risk
and so on. So that’s new therapies in the future and then there is some other assessment
that is going to be discussed that's already approved treatments. Are we - is this a third
category we are talking about here of a therapy that isn't really new and isn't really
already approved and if this were to be approved would it then go - would this be
considered just to be approved to have already completed some kind of cardiovascular
safety assessment as opposed to already approved therapies that haven't or how would
these three categories fit in together, that’s my question.
that when the guidance was published in December, it was also decided that this
requirement to assess cardiovascular risk with this picture again I say the goalpost as Dr.
Joffe had referred to before, 1.8 and 1.3 was important to apply for any therapy, any
NDA that comes before the FDA, including the ones in house. So, with that, that’s
what's going to be uniform across the board for all these programs. What becomes more
complicated are the companies who have been caught in the middle. While this - the line
has been drawn in the sand and they stood before that line. It's not just the
recommendations that you provide to us today based on the quality of these data to meet
that goalpost, is not only for these applications here but it will also help us because there
DR. PARKS: I think that it’s important for the Committee to understand
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When we analyze acute CV events, we qualitatively arrived essentially at the same
DR. BURMAN: Thank you. We have a few minutes left before lunch.
Does anybody from the committee have another question?
DR. FLEGAL: Yes. I’m trying to understand how this discussion fits into