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POZEN Receives CRL From FDA

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Monday morning, April 28, 2014, POZEN Inc. (NASDAQ: POZN) announced that its drug candidates received a complete response letter (CRL) form the United States food and drug administration.

A complete response letter is a document issued by the FDA when the drug is completed for review but questions still remain related to the approval of the new drug in its current form.

Within this document, the FDA listed that they had inspected the manufacturing facility of an active ingredient supplier and they also recorded that inspection deficiencies were found.

“Although we were hopeful for a first cycle approval, we believe that the issues raised during the inspection can be remedied to the satisfaction of the FDA. The timing of the inspection of this facility was unfortunate as the final inspection report was only issued today. Because it occurred so close to our PDUFA date, there was no opportunity to address the issues raised,” said John R. Plachetka, Chairman, President and Chief Executive Officer.

“We don't want to speculate on the timing of the resubmission of the NDA, or the timeline for eventual FDA action on that resubmission until we have had a chance to talk again with all the concerned parties, including the FDA. We will move as quickly as we can to resolve any outstanding issues. We hope to be able to provide more information about timing during our earnings call on May 8th.”

There also were not any deficiencies or insecurities related to either of its drugs.

Shares of the company are down 10.41 percent or $0.95 per share to $8.18, shares were originally down as low as $6.02 per share.

Posted-In: John R. PlachetkaEarnings News Guidance FDA

 

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