|
Quotes & Info
|
| ANIK > SEC Filings for ANIK > Form 8-K on 14-Jun-2012 | All Recent SEC Filings |
14-Jun-2012
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.
|
|