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POZEN's CEO Discusses Q2 2012 Results - Earnings Call Transcript

At this point, I would like to turn the call over to Dr. Plachetka.

John Plachetka

Thanks Stephanie, good morning to everybody and thanks for listening in today. Let me start by providing an updated on the recent interactions we’ve had with the FDA with respect to the PA32540 and the PA8140 program.

As we indicated in June we asked the FDA for and we had a teleconference to talk about the results of the 115-bioequivalence study and our NDA submission in general. My team and I feel that the call was quite productive. Still we want a written conformation on several of the issues we discussed with the FDA, because we, along with potential partners and investors, would like the maximum possible clarity about the regulatory path forward.

Both the FDA and our management team agreed during the call that the best mechanism to achieve this goal would be a Type A meeting. This pathway would allow POZEN to make a formal presentation of information and would provide the FDA with sufficient time to evaluate our data and request and formulate their response. And so we submitted our request for a Type A meeting along with our briefing package and I’m pleased to report that this request has been granted and that our type A meeting is on the calendar for late August.

Now I would like to update everyone on our European regulatory efforts. As you may remember, POZEN recently sort advise from the medicines evaluation board in the Netherlands, a potential European reference country with respect to gaining approval for two strikes of PA, PA32540 and PA1004.

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