|
Quotes & Info
|
| NEXM > SEC Filings for NEXM > Form 8-K on 25-Nov-2008 | All Recent SEC Filings |
25-Nov-2008
Other Events
On November 24, 2008, NexMed, Inc. (the "Company") entered into an amendment to the exclusive United States licensing agreement, dated November 1, 2007 (the "Agreement"), with Warner Chilcott Company, Inc. ("Warner"), for NexMed's proprietary topical alprostadil-based cream treatment for erectile dysfunction ("Vitaros®").
Pursuant to the amendment, Warner has been granted an additional 45 days, or until January 13, 2009, to review the results of the October 15, 2008 meeting (the "Meeting") with the Food and Drug Administration (FDA). The purpose of the Meeting was to gain clarification on the major deficiencies cited by the FDA in their July 21, 2008 action letter regarding the New Drug Application (NDA) for Vitaros®. As such, on or before January 13, 2009, Warner must decide whether or not they wish to continue with the development of Vitaros®. If Warner decides that it does not wish to continue with Vitaros® then the Agreement would terminate and all rights would revert back to the Company. The Agreement previously afforded Warner 45 days, or until November 29, 2008 to review such regulatory concerns.
|
|