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incorporation) | Identification No.) |
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
The FDA has advised the companies that the balance of risk versus potential benefit no longer favors continued clinical evaluation of HEPLISAV in healthy adults and children. The FDA has also advised the companies that there may be potential for an acceptable risk versus benefit profile for HEPLISAV in patients with renal failure, and requested additional information from the companies before considering further pursuit of clinical studies in those patients. Dynavax and Merck are evaluating the FDA's response in considering next steps. In the meantime, the clinical hold on the two U.S. IND Applications for HEPLI SAV remains in effect.
This current report contains "forward-looking statements," including statements related to the assessment of and next steps with respect to the FDA response to the clinical hold on HEPLISAV, whether Merck will continue our collaboration agreement and the determination of whether further clinical development of HEPLISAV will be undertaken. Actual results may differ materially from those set forth in this current report due to the risks and uncertainties inherent in our business, including difficulties or delays in development, initiation and completion of clinical trials, the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; achieving our Merck collaborative agreement objectives; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and othe r risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Dynavax Technologies Corporation | ||||||||
Date: October 22, 2008 | By: | /s/ Deborah A. Smeltzer | ||||||
Deborah A. Smeltzer | ||||||||
Vice President, Operations and Chief Financial Officer | ||||||||