Question-and-Answer Session
Operator
(Operator instructions) We will go to Eric Schmidt with Cowen & Company.
Eric Schmidt – Cowen & Company
Well thanks for taking my call. Just on the prelaunch activities, when would you estimate, something you've got to favorable recommendation of the panel and approval on August 1, what would the estimate the time delay before launching KRYSTEXXA?
David Gionco
Eric, with respect to the timing, a lot depends if there are still any label negotiations or any last-minute discussions post that August 1 PDUFA date as to when we would actually begin to begin moving product and begin the selling process. So a lot is contingent on obviously what comes in that letter. If we have a complete response and we've got to agree to labeling on August 1 then I would think, certainly within a matter of a few short months, we will have product out in the market and we should be selling.
Eric Schmidt – Cowen & Company
Okay great and in terms of the panel on the 16th, have you received the briefing materials here from the FDA and if not when do you expect to have those in your hands?
Paul Hamelin
Yes Eric, typically the way the process works is we as a company actually have to submit our briefing book first with the data of the 16th now public, typically we have to submit our briefing book one month or 30 days in advance, so quickly looking at a calendar that would signify that we are going to be submitting our briefing book next week, which is indeed true. From there than the FDA will elect when they want to supply their briefing book to us as a company and to the advisory committee members themselves, but we would anticipate that that's probably going to happen later in May or may be even in early June.
Operator
We will go next to Joseph Schwartz, Leerink Swann.
Joseph Schwartz – Leerink Swann
Hi thanks for taking the question. I was wondering if you had an idea of who would be speaking at the panel from your side as well as the advisory committee.
Paul Hamelin
Good morning Joe. On our side we’ve been working with a number of experts and external and obviously experts that we believe within our company as well. We have not actually finalized the exact rotation and who is presenting each and every different section because we continue to rehearse and we probably will not announce publicly until the advisory committee exactly who's going to be doing the presentations, but it will multiple people on behalf of the sponsor and there will be multiple people responding to questions to that arise through the course of the advisory committee.
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