Here’s an update on Dendreon. Posted on Seeking Alpha by Theodore Cohen.
Dendreon’s Provenge: Government Agencies Play Hide and Seek With Facts 
Excerpt: "On June 2, 2008, the United States Court of Appeals for the Sixth Circuit, Cincinnati, Ohio, granted CareToLive oral argument in Appeal No. 07-4465, regarding the Southern District of Ohio Court’s decision (case # 07-729). The case is scheduled to be heard on July 29, 2008, before a three-judge panel. The granting of oral argument is just the next installment of a saga that began on May 8, 2007, with the FDA’s issuance of a Complete Response Letter (“Approvable Letter”) to Dendreon in the matter of its Provenge immunotherapy for end stage prostate cancer.
Soon thereafter, CareToLive filed a Citizen Petition, requesting that the FDA reconsider its failure to approve Provenge. This action was followed by the filing of a complaint against Dr. Andrew von Eschenbach, the FDA Commissioner; Hon. Mike Leavitt, Secretary of the U.S. Department of Health and Human Services; Dr. Richard Pazdur, and FDA employee; and Dr. Howard Scher, a Special Government Employee of the FDA. Among other things, the complaint asked the Court to:
A) Enjoin the FDA from denying the marketing and sale of Provenge to androgen-independent prostate cancer patients.
B) In accordance with established United States Common Law, Plaintiffs seek to enjoin the Defendants from denying immediate access to Provenge and ask that all Defendants collectively and individually be restrained and ordered to cease and desist their interference with Dendreon’s lawful attempts to provide aid to dying patients by marketing and distributing Provenge.
C) A declaration that the FDA’s failure to approve Provenge was due to the failure of the FDA to follow its own regulations combined with the improper actions taken by Dr. Howard Scher, and Dr Richard Pazdur that improperly corrupted the process and influenced the decision not to approve Provenge on May 15th 2007.
See the entire document here."
Read full article here.
