Operation Accelerate Approval Update!
Posted in: The Cause
Today, the data was released at the American Urological Association conference, and it once again points to why the FDA needs to get the Immunotherapy Provenge to the men with late stage prostate cancer as quickly as possible!
The Provenge Impact trial showed a 38% 3-year survival rate!!
A 22.5% reduction in the risk of death!!
GREAT JOB TO ALL THE FOLKS AT DENDREON.
THIS IS GOING TO CHANGE THE WAY CANCER IS TREATED!
MUCH THANKS TO OUR ATTORNEY KERRY DONAHUE & DAVID MILLER OF BSR RESEARCH FOR BELIEVING IN THE SCIENCE, AND TED GIRGUS AND ALL THE MEN WITH PROSTATE CANCER AND THE HUNDREDS OF CARE TO LIVE MEMBERS AND SUPPORTERS.
We are asking everyone to call or write the FDA and tell them to get this to the men ASAP.
FDA Contact Information
Dr. Jesse Goodman
His division of the FDA, CBER, handled Dendreon’s BLA for Provenge
E-mail: jesse.goodman@fda.hhs.gov
Phone: 301-827-0372
Acting FDA Commissioner
E-mail: commissioner@fda.gov
Phone: 301-796-5000
Paul Richards
FDA Public Affairs - He is handling the CTL Citizens Petition
E-mail: paul.richards@fda.hhs.gov
Phone: 1-800-835-4709 or 301-827-2000
Other FDA Public Affairs people paid with our tax dollars to serve the American people:
Phone: 1-800-835-4709 or 301-827-2000
Patricia Harley
patricia.harley@fda.hhs.gov
Lanessa Hill
lanessa.hill@fda.hhs.gov
Stephen Ripley
stephen.ripley@fda.hhs.gov
Here is an overview of the data reported today, April 28, 2009:
PROVENGE extended median survival by 4.1 months compared to placebo (25.8 months versus 21.7 months)
Biotech Analyst, David Miller, told Mike Huckman at CNBC if it is over 4, it would be a home run!
PROVENGE improved 3-year survival by 38% compared to placebo (31.7% versus 23.0%)
The IMPACT study achieved a p-value of 0.032, successfully exceeding the pre-specified level of statistical significance defined by thestudy’s design (p-value less than 0.043), and PROVENGE reduced the risk of death by 22.5% compared to placebo (HR=0.775);
PROVENGE exhibited a favorable safety profile consistent with prior trials.
Provenge is safe and it shows a survival benefit.
We already knew this 2 years ago when the FDA Advisory Committee voted it 17-0 safe and 13 to 4 substantial evidence of efficacy.
We need to get this to the men now!
Here is the Dendreon News Report>>http://investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=380042&Header=NewsIt shows a 38% 3-year survival rate….22.5% reduction in risk of death! Contact your politicians and tell them to get it made available now.
Care To Live Presents Operation Accelerate Approval
Read and Leave Comments on our FDA CareToLive Citizens’ Petition Request to Reconsider the Failure to Approve Provenge >>
http://www.youtube.com/watch?v=wbggEGUaE28
Get ready to spread the word. We are not done. We don’t want to wait a year while Provenge winds its way through the approval process.
TED GIRGUS NEEDS PROVENGE YESTERDAY!
Mitchell Gold: “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 is the first active immunotherapy to show a survival benefit in a phase 3 study. It is a tremendous accomplishment for the company and it means a tremendous amount for prostate cancer patients across the world”. ”
“We showed a survival benefit, which is the gold standard outcome of oncology clinical trials, in a large randomized phase 3 trial.”
To Contact your Elected Officials
http://www.conservativeusa.org/mega-cong.htm
From DeepCapture.com
Contact the business the press
lpantages@thebeaconjournal.com; tubusiness@timesunion.com; mmurphy@abqjournal.com; mike.hirsch@mcall.com; business@azstarnet.com; kathy.tulumello@arizonarepublic.com; business@app.com; danason@ajc.com; kwarbelow@statesman.com; businessnews@baltsun.com; biznews@bhamnews.com; solomon@globe.com; business@bostonherald.com; gpotter@buffnews.com; obsbiz@charlotteobserver.com; jkane@dailyherald.com; dmiller@suntimes.com; DGreising@tribune.com; business@enquirer.com; podonnell@plaind.com; rcarter@dispatch.com; avoros@bayareanewsgroup.com; businessnews@dallasnews.com; mirby@daytondailynews.com; business@denverpost.com; lhicks@dmreg.com; business@freepress.com; biz@detnews.com; aportela@herald.com; paul.mattson@jacksonville.com; biz@star-telegram.com; business@fresnobee.com; ncrawley@grpress.com; tbarstow@patriot-news.com; dhaar@courant.com; dbutts@honoluluadvertiser.com; laura.goldberg@chron.com; steve.berta@indystar.com; clester@kcstar.com; business@knews.com; mhiesiger@reviewjournal.com; jbeach1@herald-leader.com; dnbiz@dailynews.com; bizletters@latimes.com; businessnews@courier-journal.com; joverstreet@commercialappeal.com; business@miamiherald.com; jsbiz@journalsentinel.com; ewieffering@startribune.com; kturner@mobileregister.com; dfisher@tennessean.com; money@timespicayune.com; swenger@edit.nydailynews.com; dgreenfield@nypost.com; bizday@nytimes.com; business@starledger.com; nsommers@dailypress.com; bizandtech@newsday.com; donnellon@northjersey.com; cbunyan@oklahoman.com; ghall@ocregister.com; businessnews@orlandosentinel.com; pbbusiness@pbpost.com; wwarren@phillynews.com; tgnoffo@phillynews.com; smassey@post-gazette.com; business@tribweb.com; business@news.oregonian.com; jkostrze@projo.com; mary.cornatzer@newsobserver.com; pfeibish@timesdispatch.com; rob.johnson@roanoke.com; erosen@DemocratandChronicle.com; reuteman@rockymountainnews.com; canderson@sacbee.com; mlimon@sltrib.com; blehman@express-news.net; financial@uniontrib.com; business@sfchronicle.com; business@mercurynews.com; tappel@pressdemocrat.com; margarettaus@seattlepi.com; business@seattletimes.com; alvasquez@sun-sentinel.com; scottm@spokesman.com; ekohn@post-dispatch.com; diverson@pioneerpress.com; biznews@sptimes.com; mmorelli@syracuse.com; marcelene.edwards@thenewstribune.com; mguidera@tampatrib.com; business@theblade.com; john.stancavage@tulsaworld.com; dcarroll@usatoday.com; bill.choyke@pilotonline.com; nywireroom@dowjones.com; beyersd@washpost.com; dhoneycutt@washingtontimes.com; mbieger@lohud.com; tgbiz@telegram.com
Contact The General US Press
bwinges@thebeaconjournal.com; tucitydesk@timesunion.com; kwalz@abqjournal.com; news@mcall.com; citydesk@azstarnet.com; newstips@arizonarepublic.com; editors@app.com; newstips@ajc.com; news@statesman.com; businessnews@baltsun.com; tscarritt@bhamnews.com; localnews@globe.com; citydesk@bostonherald.com; citydesk@buffnews.com; localnews@charlotteobserver.com; news@dailyherald.com; mcooke@suntimes.com; ctc-editor@tribune.com; tcallinan@enquirer.com; sgoldberg@plaind.com; bmarrison@dispatch.com; ccnnewsrelease@bayareanewsgroup.com; metro@dallasnews.com; kcanfield@daytondailynews.com; newsroom@denverpost.com; metroiowa@dmreg.com; dfpcity@freepress.com; jon.wolman@detnews.com; perspectiva@elherald.com; frank.denton@jacksonville.com; newsroom@star-telegram.com; metro@fresnobee.com; mlloyd@grpress.com; citydesk@pnco.com; julien@courant.com; mplatte@honoluluadvertiser.com; citydesk@chron.com; newstips@indystar.com; levings@kcstar.com; news@knews.com; sertado@reviewjournal.com; hlnews@herald-leader.com; dnmetro@dailynews.com; national@latimes.com; bpost@courier-journal.com; metro@commercialappeal.com; nationalnews@miamiherald.com; gstanley@journalsentinel.com; dtice@startribune.com; newsroom@mobileregister.com; local@tennessean.com; citydesk@timespicayune.com; news@edit.nydailynews.com; enorton@nypost.com; nytnews@nytimes.com; metro@starledger.com; bstertz@dailypress.com; news@newsday.com; newsroom@northjersey.com; ekelley@oklahoman.com; local@ocregister.com; editor@orlandosentinel.com; pb_metro@pbpost.com; josephg@phillynews.com; nationaldesk@phillynews.com; letters@post-gazette.com; fcraig@tribweb.com; newsroom@news.oregonian.com; pjnews@projo.com; metroeds@newsobserver.com; news@timesdispatch.com; news@roanoke.com; editor@democratandchronicle.com; editor@rockymountainnews.com; metro@sacbee.com; pegmcentee@sltrib.com; rrivard@express-news.net; jeff.rose@uniontrib.com; metro@sfchronicle.com; nation@mercurynews.com; bswofford@pressdemocrat.com; citydesk@seattlepi.com; newstips@seattletimes.com; emaucker@sun-sentinel.com; news@spokesman.com; tpoor@post-dispatch.com; news@pioneerpress.com; national@sptimes.com; mconnor@syracuse.com; newstips@thenewstribune.com; trib_news@tampatrib.com; kfranck@theblade.com; news@tulsaworld.com; kpaulson@usatoday.com; katrice.franklin@pilotonline.com; nywireroom@dowjones.com; national@washpost.com; jweber@washingtontimes.com; metro@lohud.com; newstips@telegram.com; support@abcnews.go.com; info@ap.org; release@bloomberg.net; talkback@business2.com; evening@cbsnews.com; ctc-editor@tribune.com; csmnewsdesk@csps.com; public.information@cnn.com; drudge@drudgereport.com; pr@fastcompany.com; readers@forbes.com; letters@fortune.com; americasnewsroom@foxnews.com; ibdnews@investors.com; metrodesk@latimes.com; sfoxwell@npr.org; Today@NBCUNI.com; nytnews@nytimes.com; newsahead@msn.com; editors@newsweek.com; nathan@pacifica.org; letters@time.com; letters@usnews.com; pressreleases@upi.com; theforum@usatoday.com; nywireroom@dowjones.com; metro@washpost.com; jweber@washingtontimes.com
Overstock CEO Patrick Byrne just wrote an incredible story covering part of the Dendreon Debacle. Thanks Patrick. You are the best!
Return to: Operation Accelerate Approval Update!
Social Web