Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Eric Schmidt from Cowen & Co.
Eric Schmidt - Cowen & Co.
Good morning, congratulations on the acceptance for the PLA. My question is on the review process. It seems like the FDA has got a lot to do in the next four months here and those are summer months of course. You mentioned that they need to complete inspections of Horsham and your clinical sites and obviously we think a panel is likely. So the question is are you getting their full attention, are they very much engaged and have any of these events already been scheduled?
Armando Anido
Eric, thank you very much and that is a great question. I can tell you that pretty much from the moment that we submitted the application back in late February that we are getting the full attention of the Food and Drug Administration and the Reviewing Division. They have been actively questioning us and actively working with us and we anticipate that they will live up to the PDUFA date of August 21 of ’09.
Eric Schmidt - Cowen & Co.
Armando, has a panel been scheduled and which advisory group do you expect might review this product?
Armando Anido
The Reviewing Division is the Division of Anesthesia, Analgesia, and Rheumatology, otherwise known as DAAR. We do anticipate that we will and we have been preparing for an advisory panel, but nothing is set at this point.
Eric Schmidt - Cowen & Co.
So the Rheumatology Advisory Panel as well?
Armando Anido
It will be the DAAR group.
Eric Schmidt - Cowen & Co.
Okay, thank you.
Operator
Your next question comes from Thomas Wei from Piper Jaffray & Co.
Thomas Wei - Piper Jaffray & Co.
I have a couple of questions on the hypersensitivity controversy. It might be helpful if you could share with us exactly what was seen in the phase III trials on antibodies and in particular how that antibody profile changed over time with successive injections.
Armando Anido
Let me take the question to begin with. As we have seen previously we do see antibodies that do form with the compound and for the most part almost all patients eventually do get antibodies that form to AA4500 and they happen usually in almost all patients at probably between doses three and four that they get there.
Thomas Wei - Piper Jaffray & Co
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