Question-and-Answer Session
Operator
(Operator instructions) And our first question comes from the line of Salveen Kochnover with Collins Stewart. Please proceed.
Daniel Bradbury
Hello Salveen.
Brent Kelly – Collins Stewart
Hello. Hi, this is – sorry this is Brent Kelly in for Salveen. Can you just update us on where we stand with the BYETTA monotherapy and label revision for pancreatitis and maybe your interactions in that regard with the FDA?
Daniel Bradbury
Sure, Brent. Hi, good afternoon. Yes, where we stand there is that we are continuing to have interactions with the agency on that. At this time, the agency has received from us a significant body of data with regards to pancreatitis, its prevalence in type 2 diabetes, and in particular, major epidemiology studies relating to pancreatitis and the incidence of it with respect to treatment – other treatments of type 2 diabetes as well as BYETTA. That review is ongoing and we are, I would say, cautiously optimistic that the agency will come to a conclusion in the near future.
Brent Kelly – Collins Stewart
Do you have any indication on what the hold up may be?
Daniel Bradbury
I think the agency is actually taking its time to review all data. I would say that we are very pleased that the agency has continued to be open to receiving new data. As you probably know Brent, a large amount of data was presented this year at the American Diabetes Association meeting, preclinical as well as clinical data. And I think that that data was very helpful with regards to confirming the safety of BYETTA. And I think that it’s important for the agency to continue to understand all that before coming to any conclusions.
Brent Kelly – Collins Stewart
Thank you.
Operator
And our next question comes from the line of Thomas Wei with Piper Jaffray. Please proceed.
Thomas Wei – Piper Jaffray
All right, thanks. I had a couple of questions. But first, just whether or not you could give us a sense of the feedback from the FDA on your day 74 letter and whether or not they said anything about thyroid cancer risk, and then also just wanted to get some extra details around the case of pancreatitis that you saw in DURATION-3. Thanks.
Daniel Bradbury
Hi, Thomas. Good afternoon. Well, as I commented in the script, I think I am very pleased to get the 74 day letter. It was certainly consistent with our expectations. The letter was clear and that there were no deficiencies in the – in the submission. And there were no request for additional preclinical or clinical study in the letter. They did ask for data relating to the 121 day update and consistent with the line extension strategy that we’ve employed as part of our regulatory submission.
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