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We’re Going Back To The FDA Tomorrow Wednesday 4/16/08

April 15th, 2008 | Posted by CTL
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This 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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WHATS GOING ON

This Is An Emergency!

We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.

The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK

These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.

The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.

These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.