A Story Worth Listening to: Dendreon Corporation
Published: Jan 08, 2008
Interest in Dendreon has been spurred once again since three members of Congress have asked the House Energy and Commerce Committee to hold a hearing about alleged conflicts of interest by two of the outspoken doctors who sat on the FDA panel that reviewed the prostate cancer drug and who voted against recommending approval. The news has caused shares of Dendreon to spike and since then it shares has settled down.
Currently, investors await the Phase III IMPACT trial data. The FDA review of the BLA for Provenge has lead to the FDA's request for a confirmatory trial to substantiate survival claims. In October 2007, Dendreon completed enrollment (over 500 patients) of the pivotal Phase III IMPACT trial on schedule. We will remind investors, that management expects to conduct an interim overall survival analysis of the trial in the second half of 2008 after a predetermined number of death events have occurred. The primary end point of the IMPACT trial is overall survival in men with metastatic hormone-refractory prostate cancer receiving Provenge versus placebo. Time to disease progression is a secondary endpoint. The final analysis is still expected in 2010.
Back in 2007, Provenge was issued an approvable letter by the FDA and the agency indicated that either statistically significant interim or final overall survival results from the IMPACT trial would be sufficient to support the BLA of Provenge. Dendreon’s share price could escalate as investors place their bets on the outcome of the FDA’s decision. There are plenty of regulatory arguments for and against Provenge, but we think Dendreon is worth taking a chance.
Information transmitted via BioSpace.com has been provided by publisher, Nadine Wong, of the "Biotech Sage Report" Investment Newsletter and all comments and opinions are solely those of Nadine Wong. Information provided is not guaranteed as to completeness or accuracy by Nadine Wong (the "Biotech Sage Report" publisher), BioSpace, Inc., or any person. Such Information is neither an offer to sell nor a solicitation to buy the securities of any company. The security portfolio of the editor of this newsletter, our employees, principals or affiliated companies may, in some instances, include securities and/or options on securities mentioned in each issue. Additional information is available upon request. Information in this publication has been obtained from sources believed to be reliable, but the accuracy, completeness and interpretation are not guaranteed. Opinions expressed are subject to change without notice. The Information and views provided by the "Biotech Sage Report" Newsletter are prepared by Nadine Wong, and in no way reflect the views or efforts of BioSpace, Inc., any of BioSpace's employees or officers. BioSpace, and BioSpace's employees and officers, as well as (www.biotechnav.com) Wong & Wong, Inc, and Wong & Wong Inc.'s employees and officers, in no way accept responsibility for any of the Newsletter's content.
While all reasonable care has been taken to ensure that the Information contained herein is presented in good faith, and is not untrue or misleading at the time of publication, BioSpace, Inc. and Nadine Wong make no representation as to its accuracy or completeness and it should not be relied upon as such. The Information is supplied on the condition that the reader or any other person receiving the Information will make his or her own determination as to its suitability for any purpose prior to any use of the Information. From time to time, BioSpace, Inc. and any officers or employees of BioSpace, Inc., as well as Nadine Wong and or (www.biotechnav.com) Wong & Wong, Inc., and any officers or employees of Wong & Wong, Inc., may, to the extent permitted by law, have a position or otherwise be interested in any transactions, in any investments (including derivatives) directly or indirectly in the subject of this report. Also BioSpace, Inc. and (www.biotechnav.com) Wong & Wong, Inc., may, from time to time solicit business from any company mentioned in this report. This report is provided solely for the information of viewers of BioSpace.com and/or viewers and subscribers of the Newsletters, who are expected to make their own investment decisions without reliance on this report. Neither BioSpace, Inc. nor any officer or employee of BioSpace, Inc., nor Nadine Wong or (www.biotechnav.com) Wong & Wong, Inc., or any officer or employee of Wong & Wong, Inc., accepts any liability whatsoever for any direct, indirect, special or consequential damages or loss arising from any use of this report or their contents. This report may not be reproduced, distributed or published by any recipient for any purpose without the prior express consent of the publishers. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark or copyright of BioSpace.com, Nadine Wong or (www.biotechnav.com) Wong & Wong, Inc., or any third party.
The value of the investment(s) to which this report relates and their income yield(s) may go up or down. The investment(s) referred to in this report may not be suitable for private investors: if you are in any doubt you should seek advice from your investment advisor. Changes in rates of currency exchange may have an adverse effect on the value, price or income of investments. Statements as to past performance of any investment are not a guide to future performance. The levels and bases of taxation can change, and if you are in doubt you should seek independent professional advice. In some cases it may be difficult for you to sell or realize your investment or to obtain reliable information about its value or the extent of the risks to which you are exposed.
THIS INFORMATION IS PROVIDED "AS IS" AND NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED OF ACCURACY, MERCHANTIBILITY FITNESSFOR A PARTICULAR PURPOSE OR OF ANY OTHER NATURE ARE MADE WITH RESPECT TO THIS INFORMATION OR TO ANY EXPRESSED VIEWS PRESENTED IN THIS INFORMATION.