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Posts Tagged ‘Care To Live Appeal’
Provenge is approved!
- Provenge has been approved! Thank you to all who helped achieve this important milestone for cancer patients.
LATEST POSTS
- 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
- 04/16/2011 - PROVENGE! PROVENGE! GET YOUR PROVENGE HERE!
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.
The Battle Continues — The Parties Jocky for Position Headed into Oral Argument
July 17th, 2008 | Posted by CTLKerry Donahue, Attorney CareToLive
Oral arguments
July 29th at 1:30 pm
Potter Stewart United States Court House
100 East Fifth St., Cincinnati, Ohio
The Sixth Circuit Court in Cincinnati, Ohio
Appeal No. 07-4465
Southern District of Ohio Court decision (case # 07-729)
Today the FDA sent a Federal Rule of Appellate procedure 28 letter to the Sixth District Court which you can review here.
caretolive-defs-rule-28j-letter-20080716.pdf
Our Counsel then filed a response seen here
ctlfdarule28-responsea.pdf
and his own Rule 28 letter with attachments, seen here
cctlfdarule28jlettera.pdf
Popularity: 11%
Tags: Andrew Von Eschenbach, Care To Live Appeal, CareToLive, Dendreon, DOJ, FDA, Kerry Donahue, Prostate Cancer, provenge
Posted in The Dysfunctional FDA, The Lawsuit | 3 Comments »