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POZN > SEC Filings for POZN > Form 8-K on 23-Dec-2013All Recent SEC Filings

Show all filings for POZEN INC /NC

Form 8-K for POZEN INC /NC


Other Events

Item 8.01 Other Events.

Over the past few weeks POZEN Inc. (the "Company") has been corresponding with and providing additional information to the United States Food & Drug Administration (the "FDA") concerning its New Drug Application ("NDA") for PA32540 and PA8140 tablets. In connection with these discussions, the Company has decided to conduct a comparative Phase 1 pharmacokinetic study. The goal of the study is to determine the pharmacokinetic profile of the omeprazole component of PA 8140 tablets and compare to that of PA32540 tablets. Both PA dosage forms contain 40mg of omeprazole in an immediate release form and are manufactured using nearly identical procedures.

The Company anticipates that this study, which will enroll up to 30 subjects, will cost approximately $750,000. Final data are expected to be available in March 2014. The Company and the FDA have agreed that the Company will submit study information and data to the FDA as it becomes available during the conduct of the study and that FDA will review such information and data from the study when submitted. FDA has informed the Company that the Company's user fee date (the "PDUFA Date") is now April 25, 2014.

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