Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from the line of Eric Schmidt of Cowen and Company.
Eric Schmidt – Cowen and Company
Good afternoon. Thanks for taking my questions. Ron, has the FDA received the open-label expansion data for 512?
Ron Barrett
At the time of the data cut for the 120-day safety update, we had about 376 subjects who had completed nine months and 269 who had completed a full 52 weeks of treatment in the study. So that more than exceeds the ICH guidelines, and we think that again it provides sufficient evidence of the safety – long-term safety of the drug to support the NDA.
Eric Schmidt – Cowen and Company
I guess my line of thinking was more along the lines of if you have to make amendment in your package, whether that might allow the FDA to postpone the PDUFA date or whether you think they are still working strenuously to get the stuff by November?
Ron Barrett
No, it’s very common to have continued studies ongoing at the time of NDA submission as well as 120-day update, and as I said, we think that this more than surpasses the ICH guidelines for chronic therapy and the agreement that we had with the FDA for filing the NDA. I don’t believe that that will lead to any delay.
Eric Schmidt – Cowen and Company
Okay. Your latest thoughts on whether a panel will be called to review the program?
Ron Barrett
Well, as you probably know, the new FDA legislation and the draft guidance states that all MCV [ph] should go to an advisory committee and we consider ourselves to be an MCV based on all of the discussion we’ve had with the FDA. If there is no advisory committee, the FDA is to provide a reason why that comment not required in the approval letter. I’m aware of a couple of products that recently have been approved without advisory committee; lacosamide, (inaudible). There probably are several others. So that’s about all I can say at this point, and we look forward to continue to work with the FDA and GSK on the review of the file.
Eric Schmidt – Cowen and Company
Okay. And the press release mentions the – one patient I guess from the open-label who had the serious adverse event of mental status change. Could you just give us a little bit more background on what happened there, what does serious mental status change relates to, and whether you’ve seen anything similar –?
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