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DR. TEERLINK: Just like to ask what she would surveil for?

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DR. BURMAN: I didn’t hear you John I am sorry.

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DR. TEERLINK: I would like to ask what would you surveil for?

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DR. LEVITSKY: Oh. I think that we would have to be looking for a risk

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question? Which is, are you satisfied enough that the pre-marketing data indicates there

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is a low risk and if that drug is approved that it should be approved for all patients with

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diabetes? Or would you take the view that there are insufficient data for the long-term

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and that it should only be approved for selected groups of patients with low

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cardiovascular risk, for example?

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DR. KONSTAM: Okay. I mean just to respond to your question, you

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know, I would say first I guess we should, I think we need to remind ourselves that the

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FDA has asked us about two bars, right? The first bar would be one of approvability.

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DR. LEVITSKY: Oh no.

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DR. BURMAN: Then let’s see. Mike would you mind if Marvin goes

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DR. BURMAN: Can I ask you, what I think is the critical follow up

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The other bar is, are we sure enough about the safety that no other studies are mandated?

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first then get back to you, please?

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DR. LEVITSKY: I think that this drug, given what I know about it

biologically, should probably be approved for all patients with very careful surveillance.

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DR. BURMAN: I think that’s a critical question, does anybody have a

comment on that as well?

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patients?

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of cardiac events and that’s a very, just the long-term surveillance.

DR. TEERLINK: Oh, surveillance of the data, not of the individual

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