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the guidance. The guidance talks about new therapies which have to go through or are

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recommended to prospectively adjudicate events and include patients at increased risk

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and so on. So that’s new therapies in the future and then there is some other assessment

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that is going to be discussed that's already approved treatments. Are we - is this a third

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category we are talking about here of a therapy that isn't really new and isn't really

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already approved and if this were to be approved would it then go - would this be

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considered just to be approved to have already completed some kind of cardiovascular

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safety assessment as opposed to already approved therapies that haven't or how would

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these three categories fit in together, that’s my question.

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that when the guidance was published in December, it was also decided that this

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requirement to assess cardiovascular risk with this picture again I say the goalpost as Dr.

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Joffe had referred to before, 1.8 and 1.3 was important to apply for any therapy, any

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NDA that comes before the FDA, including the ones in house. So, with that, that’s

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what's going to be uniform across the board for all these programs. What becomes more

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complicated are the companies who have been caught in the middle. While this - the line

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has been drawn in the sand and they stood before that line. It's not just the

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recommendations that you provide to us today based on the quality of these data to meet

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that goalpost, is not only for these applications here but it will also help us because there

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DR. PARKS: I think that it’s important for the Committee to understand

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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When we analyze acute CV events, we qualitatively arrived essentially at the same

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answer.

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DR. BURMAN: Thank you. We have a few minutes left before lunch.

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Does anybody from the committee have another question?

DR. FLEGAL: Yes. I’m trying to understand how this discussion fits into

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