Question-and-Answer Session
Operator
(Operator Instructions) First question comes from the line of Shar Yanni with JP Morgan, please proceed.
Shar Yanni – JP Morgan
Thank you so much for taking my call. I had a couple questions. First of all I wanted to know if the FDA draft guidelines has changed your thoughts regarding potential design of a pivotal program for diabetes.
Leland Wilson
Thanks Shar. Fortunately we have been in discussions long before the release of this document with the FDA concerning the diabetes indication. So we were fully appraised and knowledgeable about what the FDA requirements are. So it really hasn’t changed our position significantly at all.
Shar Yanni – JP Morgan
We can assume the Phase III design will follow the guideline fairly closely.
Leland Wilson
Absolutely. Now there are some considerations here. First of all they are guidelines. Second one is that we have been in discussions with the FDA prior to the release of these documents and the third one is that we’re dealing with—we’re not dealing with new chemical indices. So all those go into the mix as to what the FDA is finally giving us guidance for our Phase III program. But it’s going to follow very closely to what the advisory document recommends.
Shar Yanni – JP Morgan
And then regarding Qnexa, have you seen any fall out from the FDA alerts? Has there been any negative reaction or concern expressed by the physicians?
Leland Wilson
No. Not to my knowledge. Tim any feedback?
Timothy Morris
We haven’t seen anything, so I mean, that was probably a one day news item.
Shar Yanni – JP Morgan
And has it altered the studies consent in any way?
Leland Wilson
No, and we’re aware of the FDA class review of those anti epileptic so all that was taken into consideration in the design Phase III for obesity.
Shar Yanni – JP Morgan
That’s good to know. And then finally given that [centromin] is a controlled substance is there a need at all for a dependence or abuse potential study with Qnexa?
Leland Wilson
We haven’t finally negotiated that with FDA. When we get that done we’ll let you. But I’ll give you my personal opinion that Centramine should not be scheduled and there’s a possibility that we can get it descheduled but I’m not going to promise that at this point. We’re looking at it.
Shar Yanni – JP Morgan
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