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	<title>Stock Blog Hub &#187; PAI</title>
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		<title>(ALXA) Alexza Pharmaceuticals Files New Drug Application</title>
		<link>http://www.stockbloghub.com/2009/12/17/alxa-alexza-pharmaceuticals-files-new-drug-application/23155</link>
		<comments>http://www.stockbloghub.com/2009/12/17/alxa-alexza-pharmaceuticals-files-new-drug-application/23155#comments</comments>
		<pubDate>Fri, 18 Dec 2009 01:08:54 +0000</pubDate>
		<dc:creator>vitalstocks</dc:creator>
				<category><![CDATA[Drug Manufacturers - Other]]></category>
		<category><![CDATA[Healthcare]]></category>
		<category><![CDATA[Alexza Pharmaceuticals Inc]]></category>
		<category><![CDATA[ALXA]]></category>
		<category><![CDATA[IM]]></category>
		<category><![CDATA[Ingram Micro Inc.]]></category>
		<category><![CDATA[PAI]]></category>
		<category><![CDATA[Western Asset Income Fund]]></category>

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		<description><![CDATA[On December 14, 2009, roughly a month ahead of our forecast, Alexza Pharmaceuticals (ALXA) announced it had filed the new drug application (NDA) on AZ-004. The news follows the completion of the five non-pivotal safety and supporting studies earlier in the year, and the pre-NDA meeting held with the U.S. FDA in June 2009. In total, AZ-004 has been tested in over 1,600 patients in 13 clinical programs Incorporatedluding the two pivotal phase III trials that both met their primary endpoint. We expect the U.S. FDA will respond accepting the application around early February 2010. Assuming a standard 10-month PDUFA review, Alexza should have a response letter from the FDA by the middle of October 2010. Next up for Alexza will be securing a commercialization partnership for AZ-004. Management has ]]></description>
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