We’re Going Back To The FDA Tomorrow Wednesday 4/16/08
April 15th, 2008 | Posted by CTLThis is Week #3 of our “In Your Face” Rockville Gazette Advertising Campaign to raise awareness to the tragedy that is taking place in the prostate cancer community. While 83 men die every day of prostate cancer, the FDA sits on our Petition, and refuses to reverse their fatal decision to delay Provenge to the 30,000 men who might have benefitted from it, each year.
We will be there at 7AM. Join us!
It is over a year now, since the favorable Advisory Committee of experts picked by the FDA, voted unanimously, 17-0, that the Immunotherapy Provenge is safe, and overwhelmingly, 13-4, ( some conflicted panelists who did not disclose their conflicts were allowed to vote) that Provenge showed substantial evidence of efficacy.
The FDA decision was unprecedented in a treatment for a life threatening disease where there are no alternatives. The FDA assembled a panel at hundreds of thousands of dollars to evaluate Provenge. They overwhelmingly advised the FDA to approve.
We must remain front and center until such time as the FDA comes to its senses and reverses their flawed decision to delay Provenge.
Our Government needs to investigate the shenanigans that took place to derail the Provenge License.
The FDA must immediately approve Provenge for androgen independent/hormone refractory prostate cancer, and give Provenge its rightful license to begin using this immunotherapy for men with end stage prostate cancer.
This is an Emergency!
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Tags: , AIPC, Andrew Von Eschenbach, Brachytherapy, Care To Live, CareToLive, Chemotherapy, Demonstration, Dendreon, Dendritic Cells, FDA, hormone refractory, Howard Scher, Immunotherapy, maha hussain, Maryland, Prostate Cancer, provenge, radical prostatectomy, Richard Pazdur, Rockville, Rockville Gazette
April 15th, 2008 at 8:16 am
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April 15th, 2008 at 5:16 pm
great