Item 8.01. Other Events.
On November 2, 2009, Dendreon Corporation (the "Company") announced that it
had completed the submission of its amended Biologics License Application
(BLA) for PROVENGEŽ (sipuleucel-T), the Company's lead investigational product,
to the U.S. Food and Drug Administration (FDA). The amended BLA includes data
from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) clinical
trial, which was conducted under a Special Protocol Assessment agreement with
the FDA, as well as data responding to the FDA's previous request for additional
information regarding the chemistry, manufacturing and controls (CMC) section of
the BLA. See attached Exhibit 99.1 for the full text of the press release.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
99.1 Press release dated November 2, 2009.
