Alimera 8-K (1)
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): May 1, 2013
ALIMERA SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware | | 001-34703 | | 20-0028718 |
(State or other Jurisdiction of Incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
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6120 Windward Parkway
Suite 290
Alpharetta, Georgia | | 30005 |
(Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (678) 990-5740
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Not Applicable |
(Former name or former address if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On May 1, 2013, Alimera Sciences, Inc. (the Company) issued a press release announcing that its recent resubmission of its New Drug Application (NDA) for ILUVIEN® has been acknowledged as received by the U.S. Food and Drug Administration (FDA) as a class 2 response to the FDA's November 2011 letter, and that a Prescription Drug User Fee Act (PDUFA) goal date of October 17, 2013 has been set. The PDUFA date is the date by which the Company can reasonably expect to have received the FDA's decision with respect to the NDA. A copy of the press release is attached as Exhibit 99.1 hereto and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit No. | | Description |
99.1 | | Press Release of Alimera Sciences, Inc. dated May 1, 2013 |
SIGNATURE
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 the undersigned hereunto duly authorized.
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| ALIMERA SCIENCES, INC. |
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| By: | /s/ RICHARD S. EISWIRTH, JR. |
| | Name: Richard S. Eiswirth, Jr. |
| | Title: Chief Operating Officer and |
| | Chief Financial Officer |
Dated: May 1, 2013