Question-and-Answer Session
Operator
(Operator Instructions). We’ll take our first question from Corey Davis with Natixis.
Corey Davis - Natixis
Sol, it’s unclear to me from the two studies that you mentioned specifically, the bridging study in the Type 1 pilot, it sounds like those are going to be part of the NDA, but could you just maybe go through any other studies that you either have started or plan to start that will and will not be part of the NDA, just so we know exactly what's going to contribute to it?
Sol Steiner
I believe we mentioned one study that is in the process of starting. It’s a study to look at compare the injection site reaction, on injection of VIAject in our final formulation, to rapid-acting analog. That study will either be in the NDA or it will be submitted shortly thereafter, there is a period of 120 day safety follow-up period, where you can submit this.
We’ve already discussed that with the FDA. So, it will be in the NDA or it will be submitted shortly after we submit our NDA and the goal of that study is to show that the patients don’t have any more injection site discomfort with VIAject may do with Humalog.
Corey Davis - Natixis
Your bridging study is completed, correct?
Sol Steiner
That’s correct. We looked at that and we saw that, and that’s very encouraging. That we said, look we really wanted nail to stand definitively by doing a study that measures injection site discomfort, that’s its primary outcome measure. That’s what you are looking at and it carefully crafted to be sensitive to these things.
Corey Davis - Natixis
This new study you are talking about, will compare directly to Humalog?
Sol Steiner
That is correct.
Corey Davis - Natixis
Okay. Any other big studies that you've got?
Sol Steiner
Well, as I mentioned we are doing a pilot pump study. The pilot pump studies in Type 1 patients and we will probably use continuous glucose monitoring, not probably using continuous glucose monitoring and the goal there is to look at glycemic variability.
We believe that VIAject has a major advantage for use in pumps and the reason for that is because the time from administering to seeing a response is much shorter and the other end is equally important if not more important, the time from shutting off the pump to stopping the action of insulin is also much shorter, because the rate-limiting step on elimination is absorption. So, because it will absorb more rapidly it is eliminated more rapidly.
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