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): June 12, 2012
Anika
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Massachusetts |
000-21326 |
04-3145961 |
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
32 Wiggins Avenue Bedford, Massachusetts |
01730 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (781)
457-9000
N/A
(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:
⃞ 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))
Item 8.01 Other Events
On June 12, 2012, the company attended a supervisory appeal meeting with the Chief Scientific Officer of the Center for Devices and Radiological Health (CDRH), a branch of the United States Food and Drug Administration (FDA) to address concerns related to the non-approvable letter issued by the FDA for the company’s Monovisc Pre-market Approval application (PMA).
The meeting resulted in a productive dialogue. The FDA requested additional information in order to pass judgment on the appeal. The company plans to submit that information within two months and was promised a timely review and decision by the FDA.
The information in this Section in this Current Report is being
furnished and shall not be deemed to be "filed" for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), or otherwise subject to the liability of that Section, and shall
not be incorporated by reference into any registration statement or
other document filed under the Securities Act of 1933, or the Exchange
Act, except as shall be expressly set forth by specific reference in
such filing.
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 the undersigned hereunto duly authorized.
Anika Therapeutics, Inc. |
||||
Date: | June 14, 2012 | By: |
/s/ Kevin W. Quinlan |
|
Name: |
Kevin W. Quinlan |
|||
Title: |
Chief Financial Officer |