Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from the line of Ted Tenthoff with Piper Jaffray.
Ted Tenthoff – Piper Jaffray
Tom, you touched on this a little bit on the call, but what actually still has to be done in preparation of the NDA filing early next year, and as you look at some of the changes that are passing through with respect to Medicare and healthcare bills in general, what is the potential impact, positive or negative, on 004 and partnering discussions?
Tom King
In terms of the NDA filing, we’re in the stage right now where we are in final report writing. There are three major sections to the NDA. There is the clinical section, there is the non-clinical analytical section, all the animal toxicology, pharmacology, in vivo, and in vitro testing, and there is the CMC section. At this point in time through the next couple of months, we’re writing reporting, editing reports, uploading reports. The last report that I had that we have was almost 50,000 pages already uploaded into our contract supplier who is doing the electronic submission, so it’s a fairly weighty document, and once it gets uploaded and we through a pretty thorough QC/QA of the data of the information as it resides on their server before we actually get ready to sent it off to the FDA, so I think data collection is basically done at this point in time, and it is process related in terms of final report writing, final editing, completion of the integrated summary of safety, integrated summary of efficacy, and getting it all uploaded, doing the final QC checks and being off and running for the submission early next year.
In terms of healthcare and the healthcare debate, AZ-004 is going to be at least for its first approval in an interesting spot, I think. Agitation is not an ICD-9 or DRG, and a result of finding it difficult to find information on treating these. The other side of that coin is that it’s an area of medicine that doesn’t have I would say a lot of imposition in terms of cost per se. Patients that come into an emergency department or come into a long-term care facility are on a more capitated system no matter how that system is defined, whether it’s a private payer or a public payer, and as such a drug that can facilitate throughput, a drug that can facilitate maybe not using restraints and not having to write reports about using restraints, a drug that doesn’t have to have someone sit with them as they get an old drug that might not work as fast are all components to a very strong overall health economic argument, and we believe that even though there is a lot of froth obviously in the healthcare debate around the United States currently, AZ-004 to a large degree is outside what that froth or what discussion might be.
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