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Strategies & Market Trends : YEEHAW CANDIDATES -- Ignore unavailable to you. Want to Upgrade?

To: brogan who wrote (11709)	9/14/2005 1:14:43 PM
From: Joseph B. Schmidt	Read Replies (1) \| Respond to of 23958

Another candididate w/ large short interest: Dendreon Announces Plans to Submit Application for FDA Approval of Provenge for the Treatment of Advanced Prostate Cancer Company to Host Conference Call Today at 4:00 p.m. ET Sep 14, 2005 1:00:00 PM SEATTLE, Sept. 14 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to market Provenge(R), the Company's investigational immunotherapy for the treatment of advanced prostate cancer. This decision follows a recent pre-BLA meeting in which the Company reviewed safety and efficacy data with the FDA from its two completed Phase 3 clinical trials of Provenge in patients with advanced prostate cancer. The outcome of these discussions determined that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies is sufficient to serve as the clinical basis of a BLA submission for Provenge. The Company will host a conference call today at 4:00 p.m. ET. "Our decision to move forward with a BLA submission is based on feedback we have received from the FDA in a recent pre-BLA meeting," said Mitchell H. Gold, M.D., Dendreon's president and chief executive officer. "We look forward to working closely with the FDA to bring what could be the first cancer immunotherapy agent to market for the many men with advanced prostate cancer who have few appealing treatment options." Prostate cancer is the number one non-skin cancer in the United States. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year from the disease. D9901 and D9902A Phase 3 Study Results As reported earlier this year, the final three-year follow up of the D9901 Phase 3 study of Provenge in 127 men with asymptomatic, metastatic, androgen- independent prostate cancer showed a median survival benefit of 21 percent or 4.5 months and a three-fold improvement in survival at 36 months (p-value = 0.01; hazard ratio = 1.7) for patients who were randomized to receive Provenge compared to placebo. This hazard ratio implies that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge. Final three-year follow up of the D9902A Phase 3 study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. In both studies, as in previous studies, Provenge was well tolerated with the most common adverse events reported being fever and chills lasting for one to two days. About Provenge Provenge is designed to stimulate a patient's immune system against prostate cancer. It is developed through Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes a recombinant form of an antigen found in 95 percent of prostate cancers, prostatic acid phosphatase (PAP). Provenge is being further evaluated in an ongoing Phase 3 study in asymptomatic, metastatic, androgen-independent prostate cancer (D9902B). It is also being evaluated in a Phase 3 trial, known as PROTECT or P-11, in men with earlier stage prostate cancer. Conference Call Details LIVE Access on September 14, 2005, 4:00 p.m. ET; 1:00 p.m. PT: -- Phone 800-818-5264 (domestic) or +1-913-981-4910 (international) -- Webcast connection through the Dendreon website at www.dendreon.com in the Investors/Webcast section. REPLAY Access: -- Phone replay, available for 3 days by calling 888-203-1112 (domestic) or +1-719-457-0820 (international); Passcode: 9475792 -- Webcast replay is available for 90 days from the Dendreon website at www.dendreon.com in the Investors/Webcast section. About DendreonDendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the development of innovative cancer treatments. In addition to its immunotherapies in clinical and preclinical development for a variety of cancers, Dendreon's product pipeline also includes monoclonal antibody and small molecule product candidates. Dendreon has research and development alliances with Genentech, Inc., Abgenix, Inc. and Dyax Corp. For more information about the company and its programs, visit www.dendreon.com. Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of Provenge to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of a clinical trial for Provenge will not support an application for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for Provenge or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of Provenge, our dependence on the efforts of third parties, including collaborators, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations is contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. SOURCE Dendreon Corporation ---------------------------------------------- Monique Greer Sr. Director Corporate Communications of Dendreon Corporation +1-206-829-1500

To: brogan who wrote (11709)	9/14/2005 1:17:29 PM
From: Galirayo	Read Replies (1) \| Respond to of 23958

[NANX] It may be cheap today Brogan .. But I think giving the Market the 50 cents or so till it's over the 50dma would be my thought. stockcharts.com[w,a]dacayiay[db][pb50!c20!f][vc60][iut!Ua12,26,9!Uv25]&pref=G