UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): November 1, 2007
POZEN INC.
(Exact Name of Registrant as Specified in Charter)
| | | | | |
Delaware | | 000-31719 | | 62-1657552 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
| | | |
1414 Raleigh Road, Suite 400 Chapel Hill, North Carolina | | 27517 |
(Address of Principal Executive Offices) | | (Zip Code) |
(919) 913-1030
(Registrant’s telephone number,
including area code)
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K is intended to simultaneously satisfy the filing obligation of the registrant under any of the followingprovisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425). |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12). |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)). |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)). |
On November 1, 2007, POZEN Inc., a Delaware corporation (“POZEN”) announced that the U.S. Food and Drug Administration (the“FDA”) has accepted for review POZEN’s amended response to the August 1, 2007 Approvable Letter for Trexima™. POZEN expects a Class II review, which could result in a new decision date of April 15, 2008. The full text of the press release is set forth in Exhibit 99.1 hereto and incorporated herein.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by theundersigned hereunto duly authorized.
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| POZEN INC. |
| | |
| By: | | |
| Name: | | William L. Hodges |
| Title: | | Chief Financial Officer |
Date: November 1, 2007
