This excerpt taken from the ZGEN 8-K filed Jun 30, 2008.
Item 8.01 Other Events.
On June 30, 2008, the Company issued a press release relating to the funding arrangement with the Deerfield Funds, a copy of which is filed herewith as Exhibit 99.1 and incorporated herein by reference.
This excerpt taken from the ZGEN 8-K filed Aug 22, 2007.
Item 8.01. Other Events.
On August 22, 2007, ZymoGenetics, Inc. (the Company) provided a status report on the regulatory review process for rThrombin. The Company reported in a conference call that it has received notification from the U.S. Food and Drug Administration (FDA) that the submission of additional manufacturing related information has been determined by the FDA to be a major amendment to the rThrombin Biologics License Application. Accordingly, the goal date for completion of FDA review under the Prescription Drug User Fee Act has been extended by three months, from October 18, 2007 to January 17, 2008.
The Company also reported certain updates to financial guidance, including the following:
This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of the Company. These statements are not guarantees of future actions or performance and may involve risks and uncertainties that are difficult to predict. The Companys actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with its unproven discovery strategy, preclinical and clinical development, regulatory oversight, intellectual property claims and litigation and other risks detailed in the companys public filings with the Securities and Exchange Commission, including the Companys Annual Report on Form 10-K for the year ended December 31, 2006. Except as required by law, the Company undertakes no obligation to update any forward-looking or other statements in this report, whether as a result of new information, future events or otherwise.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.