Question-and-Answer Session
[Operator Instructions]. Our first question comes from Thomas Wei with Piper Jaffray. Your line is open.
Thomas Wei - Piper Jaffray
Hi, thanks very much. I had a couple of questions, just first on the pre-NDA meeting, you mentioned that it was actually in the second quarter, have you had a chance to talk to the FDA, since the panel vote to just confirm the adequacy of Duration One, in light of how [inaudible] there?
Daniel M. Bradbury - President and Chief Executive Officer
Hi, Thomas yes , thanks for the question. You're right, we didn't say within the second quarter, and that the FDA panel meeting was actually subsequent to that. I'd make a note that, Thomas, you know... the FDA panel meeting was really focused on cardiovascular risk associated with new chemical entities and that's what the major difference is here, that I think, I emphasized in the call and I'd re-emphasize to you again. The exenatide once weekly strategy is a line extension regulatory strategy and it really takes into account, the entire safety database that we have with Exenatide. BYETTA has been on the market now for over three years, we have over a million people have been exposed to it and met clearly the strategy that the agency is undertaking. I'd also further emphasize, Thomas, as you think about the profile that we have with exenatide, this is a compound which lowers body weight, has a low risk of hypoglycemia and most importantly I think as you noted in one of your writings earlier this year, we look at cardiovascular surrogate endpoint, all of those are going in the right direction, blood pressure goes down, triglycerides goes down, LDL goes down, HDL goes up. So in terms of cardiovascular risk, we are actually in a strong position as a company and therefore I think the agency was fully cognizant of that at the time that we had the meeting with them in June.
Thomas Wei - Piper Jaffray
And also in the pre-NDA meeting, when you talk to FDA about the IVIVC studies and the crossover strategy is kind of unconventional alternative to bioequivalence, what did they actually say? In theory, if you have good data, do they endorse either one or both of those approaches?
Daniel M. Bradbury - President and Chief Executive Officer
As I mentioned, certainly I would just leave you with the thought that if we are able to provide the data in the format and to meet the requirements of the agency with regard to the IVIVC and/or the crossover study from DURATION-1 extension, we will be able to accelerate the submission time line. One thing I did mention on the call that there are specifics of the interactions that we had with the agency and elements of the pre-NDA meeting that we are not able to share with you in this time. And that's really making sure that we don't get ahead of ourselves and making sure that we don't speculate on potential FDA reaction to the data that we are going to generate from those studies going forward.
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