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	<title>PSA Rising Prostate Cancer Blog &#187; FDA</title>
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	<link>http://www.psa-rising.com/blog</link>
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		<title>Dendreon to seek Provenge approval in November &#8211; Reuters</title>
		<link>http://www.psa-rising.com/blog/2009/09/dendreon-to-seek-provenge-approval-in-november-reuters/</link>
		<comments>http://www.psa-rising.com/blog/2009/09/dendreon-to-seek-provenge-approval-in-november-reuters/#comments</comments>
		<pubDate>Thu, 24 Sep 2009 14:57:22 +0000</pubDate>
		<dc:creator>jacquie strax</dc:creator>
				<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[Dendreon]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://www.psa-rising.com/blog/?p=2017</guid>
		<description><![CDATA[Reuters and WAll Street Journal report today that Dendreon plans to seek US FDA approval for Provenge prostate cancer vaccine in November. Dendreon  &#8220;expects regulators to act on the application by the middle of next year, the company said on Thursday.&#8221;
To start from an updated report in the Wall Street Journal, which adds this [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2009/09/dendreon-to-seek-provenge-approval-in-november-reuters/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Video of FDA hearing on Provenge March 29th</title>
		<link>http://www.psa-rising.com/blog/2007/06/video-of-fda-hearing-on-provenge-march-29th/</link>
		<comments>http://www.psa-rising.com/blog/2007/06/video-of-fda-hearing-on-provenge-march-29th/#comments</comments>
		<pubDate>Thu, 07 Jun 2007 14:08:29 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[video]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/06/07/video-of-fda-hearing-on-provenge-march-29th</guid>
		<description><![CDATA[A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.
A full written transcript in .pdf including the voting is online at FDA, click here. 
]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/06/video-of-fda-hearing-on-provenge-march-29th/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Prostate cancer patients, families, rally in Washington D.C.</title>
		<link>http://www.psa-rising.com/blog/2007/06/prostate-cancer-patients-families-rally-in-washington-dc/</link>
		<comments>http://www.psa-rising.com/blog/2007/06/prostate-cancer-patients-families-rally-in-washington-dc/#comments</comments>
		<pubDate>Wed, 06 Jun 2007 04:45:51 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Activism]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/06/05/prostate-cancer-patients-families-rally-in-washington-dc</guid>
		<description><![CDATA[
A crowd of about 70 people led by prostate cancer advocates marched and rallied in  Washington, D.C. on June 4 to call on the FDA to Approve  Provenge Now.  

Thomas Farrington of Prostate Health Education Network addressed the group.

Raise a Voice  organizer Jan Manarite  introduced speakers including Tom  Farrington [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/06/prostate-cancer-patients-families-rally-in-washington-dc/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Prostate Cancer Doctor Receives Death Threat Over Provenge</title>
		<link>http://www.psa-rising.com/blog/2007/06/prostate-cancer-doctor-receives-death-threat-over-provenge/</link>
		<comments>http://www.psa-rising.com/blog/2007/06/prostate-cancer-doctor-receives-death-threat-over-provenge/#comments</comments>
		<pubDate>Mon, 04 Jun 2007 04:25:39 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[Dendreon]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/06/03/prostate-cancer-doctor-receives-death-threat-over-provenge</guid>
		<description><![CDATA[Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon&#8217;s Provenge therapeutic vaccine for prostate cancer.  Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.

The background to these threats goes back to March 29, when [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/06/prostate-cancer-doctor-receives-death-threat-over-provenge/feed/</wfw:commentRss>
		<slash:comments>4</slash:comments>
		</item>
		<item>
		<title>Provenge and the attack on FDA</title>
		<link>http://www.psa-rising.com/blog/2007/05/provenge-and-the-attack-on-fda/</link>
		<comments>http://www.psa-rising.com/blog/2007/05/provenge-and-the-attack-on-fda/#comments</comments>
		<pubDate>Sun, 20 May 2007 20:31:27 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/05/20/provenge-and-the-attack-on-fda</guid>
		<description><![CDATA[FoxNews (&#8221;Fair and Balanced&#8221;) aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007.  Paul Gigot interviewed  Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by  President Bush in 2005, returned to Wall Street where he  promotes Dendreon&#8217;s [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/05/provenge-and-the-attack-on-fda/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>FDA Alert for &#8216;True Man&#8217; and &#8216;Energy Max&#8217;</title>
		<link>http://www.psa-rising.com/blog/2007/05/fda-alert-for-true-man-and-energy-max/</link>
		<comments>http://www.psa-rising.com/blog/2007/05/fda-alert-for-true-man-and-energy-max/#comments</comments>
		<pubDate>Fri, 18 May 2007 19:40:58 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Complementary + Alt Med]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/05/18/fda-alert-for-true-man-and-energy-max</guid>
		<description><![CDATA[The Food and Drug Administration (FDA) is advising consumers not to purchase or use &#8220;True Man&#8221; or &#8220;Energy Max&#8221; products promoted and sold as dietary supplements throughout the United States. Both products &#8212; touted as sexual enhancement products and as treatments for erectile dysfunction (ED) &#8212; contain potentially harmful, undeclared ingredients.The products contain substances called [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/05/fda-alert-for-true-man-and-energy-max/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Raise A Voice Writes to FDA Advisory Committee</title>
		<link>http://www.psa-rising.com/blog/2007/05/raise-a-voice-writes-to-fda-advisory-committee/</link>
		<comments>http://www.psa-rising.com/blog/2007/05/raise-a-voice-writes-to-fda-advisory-committee/#comments</comments>
		<pubDate>Mon, 07 May 2007 12:03:09 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Awareness Events]]></category>
		<category><![CDATA[Dendreon]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Raise a Voice]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/05/07/raise-a-voice-writes-to-fda-advisory-committee</guid>
		<description><![CDATA[Raise a Voice, an advocacy group for advanced prostate cancer patients, which is calling for patient access to drugs that have passed through Phase I trials, has written a thank you letter  to the FDA Advisory Committee on Dendreon&#8217;s sipuleucel-T (Provenge).

The letter is signed by 19 prostate cancer advocacy groups including US Too International [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/05/raise-a-voice-writes-to-fda-advisory-committee/feed/</wfw:commentRss>
		<slash:comments>0</slash:comments>
		</item>
		<item>
		<title>Second oncologist asks FDA to wait on Provenge</title>
		<link>http://www.psa-rising.com/blog/2007/04/second-oncologist-asks-fda-to-wait-on-provenge/</link>
		<comments>http://www.psa-rising.com/blog/2007/04/second-oncologist-asks-fda-to-wait-on-provenge/#comments</comments>
		<pubDate>Thu, 26 Apr 2007 17:31:35 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Maha Hussain M.D]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/04/26/second-oncologist-asks-fda-to-wait-on-provenge/</guid>
		<description><![CDATA[Dr. Maha Hussain (left) is calling for an open access program for Dendreon&#8217;s Provenge prostate cancer vaccine (Sipuleucel-T) pending completion of an ongoing, 500 man clinical trial, She made this suggestion March 29 during the FDA Advisory Committee hearing after voting &#8220;No&#8221; on the vaccine&#8217;s efficacy.  She followed up with a letter to the [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/04/second-oncologist-asks-fda-to-wait-on-provenge/feed/</wfw:commentRss>
		<slash:comments>10</slash:comments>
		</item>
		<item>
		<title>A call for open access to Dendreon&#8217;s prostate cancer vaccine</title>
		<link>http://www.psa-rising.com/blog/2007/04/a-call-for-open-access-program-prostate-cancer-vaccine/</link>
		<comments>http://www.psa-rising.com/blog/2007/04/a-call-for-open-access-program-prostate-cancer-vaccine/#comments</comments>
		<pubDate>Thu, 26 Apr 2007 17:09:42 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Maha Hussain M.D]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/04/26/a-call-for-open-access-program-prostate-cancer-vaccine/</guid>
		<description><![CDATA[Dr. Maha Hussain, an oncologist who was one of 4 out of 17 members of the FDA Advisory Committee to vote against accepting against the company&#8217;s claim to efficacy for Provenge (Sipuleucel-T) prostate cancer vaccine, is calling for an expanded access program to empower patients who want and need it to receive the drug while [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/04/a-call-for-open-access-program-prostate-cancer-vaccine/feed/</wfw:commentRss>
		<slash:comments>2</slash:comments>
		</item>
		<item>
		<title>Scher to FDA about Provenge hearing</title>
		<link>http://www.psa-rising.com/blog/2007/04/scher-to-fda-about-provenge-hearing/</link>
		<comments>http://www.psa-rising.com/blog/2007/04/scher-to-fda-about-provenge-hearing/#comments</comments>
		<pubDate>Tue, 17 Apr 2007 15:35:54 +0000</pubDate>
		<dc:creator>admin</dc:creator>
				<category><![CDATA[Clinical trials]]></category>
		<category><![CDATA[Prostate Cancer]]></category>
		<category><![CDATA[Provenge]]></category>
		<category><![CDATA[Vaccines]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Howard Scher MD]]></category>

		<guid isPermaLink="false">http://psa-rising.com/blog/index.php/2007/04/17/scher-to-fda-about-provenge-hearing</guid>
		<description><![CDATA[This is the text of Howard Scher M.D.&#8217;s letter to FDA about the March 29th advisory committee hearing on Dendreon&#8217;s vaccine Sipuleucel-T (Provenge):
I am writing to express concerns about the recent review of Sipuleucel-T at the FDA Advisory Meeting on March 29, 2007. These concerns are: a recommendation for approval based on data that fall [...]]]></description>
		<wfw:commentRss>http://www.psa-rising.com/blog/2007/04/scher-to-fda-about-provenge-hearing/feed/</wfw:commentRss>
		<slash:comments>6</slash:comments>
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