DR. TEERLINK: Just like to ask what she would surveil for?
DR. BURMAN: I didn’t hear you John I am sorry.
DR. TEERLINK: I would like to ask what would you surveil for?
DR. LEVITSKY: Oh. I think that we would have to be looking for a risk
question? Which is, are you satisfied enough that the pre-marketing data indicates there
is a low risk and if that drug is approved that it should be approved for all patients with
diabetes? Or would you take the view that there are insufficient data for the long-term
and that it should only be approved for selected groups of patients with low
cardiovascular risk, for example?
DR. KONSTAM: Okay. I mean just to respond to your question, you
know, I would say first I guess we should, I think we need to remind ourselves that the
FDA has asked us about two bars, right? The first bar would be one of approvability.
DR. LEVITSKY: Oh no.
DR. BURMAN: Then let’s see. Mike would you mind if Marvin goes
DR. BURMAN: Can I ask you, what I think is the critical follow up
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?
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.
DR. BURMAN: I think that’s a critical question, does anybody have a
comment on that as well?
of cardiac events and that’s a very, just the long-term surveillance.
DR. TEERLINK: Oh, surveillance of the data, not of the individual