8K
10-Jul-2007
Other Events
Item 8.01. Other Events.
On July 2, 2007, Dendreon's Board of Directors received a letter dated June 28, 2007 from counsel for Harriet Goldstein IRA, a Dendreon stockholder claiming damage to the Company from alleged wrongful disclosure and insider trading and demanding that the Board investigate and take legal action against certain Dendreon officers and directors. The wrongful disclosure allegations stem from Dendreon's disclosures surrounding correspondence with the FDA during the first half of 2007 pertaining to the Company's Biologics License Application filed with the FDA for Provenge. This potential claim is not against the Company. The Company's Board of Directors will be evaluating a response to the letter. On July 9, 2007, Dendreon Corporation (the "Company") received a letter from the New York Regional Office of the Securities and Exchange Commission (the "SEC") dated July 3, 2007, notifying the Company of an informal inquiry related to the Company's clinical trials for Provenge®, the Company's Biologics License Application for Provenge filed with the U.S. Food and Drug Administration ("FDA"), and the FDA's review of Provenge and related correspondence to and from the Company, from January 1, 2007 through the present. The SEC's letter notes that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws has occurred nor should it be considered a reflection upon any person, entity or security.
The Company intends to cooperate fully with the SEC staff and respond to the staff's request for information. The Company does not intend to comment on any aspect of the inquiry or possible outcomes until the inquiry is completed.
