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POZEN's CEO Presents At Update Conference (Transcript)

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

John R. Plachetka

Thanks Stephanie, good morning and thanks for listening in today. Let me start by talking about this brief statement and we’ll open the call up for questions. I hope you had a chance to read our press release on the outcome of the Type A meeting we had with the FDA this week. And although you can probably tell from the press release that this is a positive outcome, we wanted to provide you an opportunity to get some of your more specific questions answered.

But first, let me just reiterate how pleased I am that we now feel we have a path forward to include both doses in the NDA, giving clinicians and patients a choice of a low and a high-dose version of PA. We’ve been asked many times over the years of this development program, why did we just make the 32540 when it seems that most patients take a lower dose, in fact they do. Well, now we have the best answer, and that is that we’re developing both strengths.

Our clinical and market research data suggests that two-thirds of the aspirin used for cardioprotection is at the lower dose, and about one-third is at the 325 milligram dose. So being able to include both doses in the NDA, not only will be able to offer patients a choice if both products are approved, but PA could be used by all aspirin patients who might be at risk for gastric ulcers instead of just the one-third of the patients who use 325. So that’s a nice impact on the market opportunity.

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