On November 29, 2006, the United States Food and Drug Administration, or the FDA, issued a Warning Letter to the Company. The Company received the Warning Letter on December 1, 2006 but because the Warning Letter was not sent to the regulatory contact on file with the FDA, and the actual addressee was out of the office for several days at the time, the package was consequently misplaced unopened. The Warning Letter was opened and read on December 13, 2006. The Warning Letter will be posted to the FDA’s website at www.fda.gov