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Posts Tagged ‘Mitchell Gold’
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.
DENDREON Scores a TOUCHDOWN with PROVENGE
April 14th, 2009 | Posted by Rory KearneyHISTORY WAS MADE TODAY!
A non toxic, non invasive Immunotherapy to strengthen the body’s ability to fight prostate cancer achieved its goal of being supportive of the previous trials, as required by the FDA.
Mitchell Gold, Dendreon CEO, held a conference call to announce the results of the Provenge Impact Trial.
Here are some of Dr. Gold’s words concering the results: “met its pre specified end points” “confirms results of previous studies” “data met criteria and specifications of Biologics License Application” “results were robust” “results were unambiguous and held up to multiple sensitivity analysis” “a clear hit on statistical significance”.
It was great news for long suffering prostate cancer patients who are one step closer to gaining access to Provenge.
It was great news for people around the world seeking better, more humane treatments to fight cancer. Dendreon has a pipeline of immunotherapies on the back burner.
Here at Care To Live we are ecstatic. However our work is very far from over. We need the FDA to allow the men access to Provenge NOW!
We are already getting emails from people begging for access. The FDA needs to heed their cries, and speed the approval process through. These men have already been waiting for 2 years while the FDA dawdled. They don’t have the luxury of wasting more time.
Mike Kearney had written to Andrew Schorr of Patient Power, to keep him updated. Mr. Schorr did a breaking news interview with Dr. Sam Chang, a Urologist from Vanderbilt University to find out what he thought about Dendreon’s announcement today.
At the end of the interview, Andrew said “Doctor, you sound really excited about this.” The doctor said, “Yes, not only for prostate cancer but for other cancers as well.”
http://www.patientpower.info/
Our thanks go out to the entire DENDREON team in Seattle, Washington and Hanover, New Jersey for their hard work and unending dedication, and to all the Care To Live members and supporters along with Attorney Kerry Donahue for making this day possible.
Special thanks to our devoted webmaster Matt Jurmann of ChromaticSites.com
We urge the FDA to move swiftly.
Popularity: 14%
Tags: Andrew Schorr, Care To Live, CareToLive, CareToLive.com, Dendreon, Immunotherapy, Kerry Donahue, Mitchell Gold, Prostate Cancer, provenge
Posted in The Cause, The Dysfunctional FDA | 2 Comments »