Question-and-Answer Session
Operator
(Operator's instruction) Your first question comes from the line of Thomas Wie - Piper Jaffray.
Thomas Wie - Piper Jaffray
I wanted to get your sense given what you referred to as some of the controversies that people have been raising around the regulatory review. What do you think the primary points of debate are going to be on the AFRESA clinical package when it goes to an FDA panel? What are the primary points that the panel is going to be asked about?
Peter C. Richardson
Thomas, I think that is predicting what will be the topic of an FDA review panel. It is actually quite complex at the present stage but I can say I think we would actually really look forward to the opportunity of presenting our case at such a panel. I think the discussion that I can see is one, in terms of the efficacy and how to actually translate some of the benefits that we have seen in terms of hypoglycemia. What the difference is between the Type 1 and Type 2 population because I think it is much clearer that the very strong data that we have in the Type 2 population showing reductions in hypoglycemia mild, moderate and severe are not actually clear in the Type 1 and I think that is partly because we have got further things to learn in terms of how to handle the AFRESA and the more importantly, the background basal insulin and I think there will be discussions in terms of pulmonary function testing.
We presented a very robust package of pulmonary function data. Probably one of the largest that the agency have seen, certainly one of the largest that I know in terms of in passing an inhaled track, both data I think support very clearly no clinical indication using pulmonary function testing. In fact, when we talked about this and when we looked at the lack of outliers in our database and the lack of concerning changes in pulmonary function, we believe that the best tool for looking at this is to use a doctor's stethoscope and their own clinical acumen and deciding which patients are right for AFRESA. We said the patients with underlying lung disease will not be suitable.
Those are the scenarios in terms of where I think we would anticipate most debate. As we have said, we have a robust set of data around the cardiovascular numbers. We have actually generated a relative risk and essentially one and compared to other programs in diabetes because of the need for the longer term pulmonary function data giving us two years of exposure in substantial body of the patients as well as the two one year studies that we have done. We actually have event rates and numbers which present quite a number of cardiovascular events and they show an absolutely no excess so I think that will be very important as well as the agencies dealing with that.
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