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Posts Tagged ‘Bellinger & Donahue’
Provenge is approved!
- Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
LATEST POSTS
- 02/06/2012 - Great Provenge News Released At ASCO
- 11/27/2011 - Care To Live Board Member Ted Girgus Dies of Prostate Cancer
- 09/06/2011 - Care To Live Update on SEC OIG Investigation into April 28, 2009 Dendreon Bear Raid
- 07/13/2011 - 3 Minute Video Explaining Provenge Treatment
- 06/20/2011 - Abigail Alliance Plans FDA PROTEST June 28
- 06/09/2011 - RIP Charles A. Reinwald — Cancer Cure Coalition Founder
- 04/29/2011 - Care To Live Submits Moment of Silence to CMS
- 04/28/2011 - HHS Desperately Needs Transparency Lessons From CMS
- 04/23/2011 - Please Post for Provenge!
- 04/19/2011 - Another Interim Provenge Prostate Cancer Immunotherapy CMS FOIA Response
MOST POPULAR
- Setting the Record Straight
- Provenge Is Approved But The Lies Continue
- Provenge Works & Costs the Same as Chemo & Comments by Bishop
- The Bloodshed, Bogus Threats, Birth Defects, Bashers Cover Letter
- PROVENGE WILL BE COVERED BY MEDICARE
- CareToLive sends a Freedom of Information Request to the Centers for Medicare & Medicaid Services
- ASCO Tells CMS It Should Cover Provenge
- The Centers for Medicare and Medicaid Services are requesting comments.
- Dr. Snuffy Myers Advocates For Provenge Treatment
- Senators Specter and Kerry - CMS Has Some 'Splaining To Do
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.
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.
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.
KERRY DOES IT AGAIN! OUR APPEAL REPLY IS FILED!!
February 28th, 2008 | Posted by CTLFIGHTING FOR THE RIGHTS OF THE MEN WITH PROSTATE CANCER THAT THE FDA, DR. HOWARD SCHER & DR. MAHA HUSSAIN COULD CARE LESS ABOUT.
excerpt:
The FDA, with the help of a slew of in house attorneys, has created a labyrinth of regulations, all designed to avoid oversight and minimize due process. One of the latest creations of the FDA is the Complete Response Letter (“CR”), which is a very important, yet still unseen document in this litigation. In the magical world of the FDA they have created a mechanism that Houdini would be proud of. They turned a functionally final decision, into a self declared non-final decision. The issuance of the CR letter, that essentially is believed to say come back and see us in one, two, three or more years, when, or if, you get more data, is no different in application or in function than an outright denial of the application, yet the FDA forces people to accept their contrived definition, which is that a “Complete Response” letter is not a “final response” or even a decision, and that there is still an ongoing process, as they might still approve the application sometime in the nebulous future. In Provenge’s case, the CR letter operates to the applicant, the dying patients, the patient’s families, and everyone else waiting for the treatment, as a complete denial. A CR letter is just the latest fiction created to avoid oversight. Continue Reading KERRY DOES IT AGAIN! OUR APPEAL REPLY IS FILED!! »
Popularity: 9%
Tags: Andrew Von Eschenbach, Bellinger & Donahue, Dendreon, FDA, Howard Scher, Immunotherapy, Kerry Donahue, maha hussain, Prostate Cancer, provenge
Posted in The Cause, The Lawsuit | 2 Comments »
Appellant CareToLive’s 6th Circuit Court of Appeals Brief
January 14th, 2008 | Posted by CTLCareToLive Believes that the lower Court was in error when it chose to summarily dismiss our lawsuit against the FDA, Richard Pazdur and Howard Scher along with our motion for emergency injunctive relief. We will never stop fighting until this injustice is overturned.
Click here to
read the brief requesting oral argument filed today.
Popularity: 7%
Tags: , Andrew Von Eschenbach, Bellinger & Donahue, Brachytherapy, Care To Live, CareToLive, Dendreon, FDA, Howard Scher, Immunotherapy, John Fish, Kerry M. Donahue, Marilyn Fish, Prostate Cancer, Prostate Gland, provenge, Richard Pazdur
Posted in The Lawsuit | 1 Comment »