Question-and-Answer Session
Operator
Thanks very much. (Operator instructions) Our first question today comes from Corey Davis from Natixis.
Corey Davis – Natixis
Thanks very much. I have a couple of questions. First, Sol, when you left the FDA, were you smiling or cursing?
Sol Steiner
It is bigger than a bread box.
Corey Davis – Natixis
Fair enough. Second, in your bioequivalence study, I see that the IU difference but was the volume exactly proportional, in other words the volume was 1/4 less in a higher IU?
Sol Steiner
Yes, that is correct.
Corey Davis – Natixis
And third question, trying to get a difference between the pk and the pd for these two different insulins and I am assuming that the assay you used is the standard pk stuff for bioequivalence. So a, is that true and then b, is it possible that the FDA will ask you to look at something like glucose, because you could imagine the scenario where the injected insulin could – because of its different formations, have different functionality within the body and so yes, the insulin is there in the same amounts, but how do you know whether it is truly lowering glucose in exactly the same manner?
Sol Steiner
It is a good question, Corey. Let me answer the question. We get these studies so that we could use the data for both the Ford and Drug Administration in the United States and EMEA in Europe. Now the FDA only requires for bioequivalence, they only require pharmacokinetic data. But the EMEA requires pharmacodynamic data as well and we collected that data as well, so that we could meet the requirements in Europe. And we did that through the use of a glucose clamp study. On the glucose clamp study is – in many respects, it is the gold standard for measuring the pharmacodynamic effects of insulin. You see how much glucose you have to pump into the patient over time to keep their blood glucose in the normal range of about 90 to 110 mg per desolater. And that is the pharmacodynamic measurement. So we looked at that as well and we came out the same. Did that answer you question?
Corey Davis – Natixis
Yes, it did. I was waiting for the punch line there, it is identical or –?
Sol Steiner
It is not different. There is nothing that is ever identical, but there is no difference in the formulations.
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