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braden

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braden

Re: None

Saturday, 06/18/2011 1:06:54 PM

Saturday, June 18, 2011 1:06:54 PM

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ALXA First FDA response......
Specifically, the agency was concerned about decreases in forced expiratory volume in one second (FEV1), which were seen in subjects treated with AZ-004 as well as those administered the Staccato device minus the drug as placebo. (See BioWorld Today, Oct. 12, 2010.)

After watching its stock price plummet 50 percent, Alexza set to work addressing the FDA's concerns. The company completed an end-of-review meeting with the agency in late December 2010 and plans to resubmit its AZ-004 approval application in July. A European approval filing is expected to follow in the third quarter.

Get your swing trade ideas at http://investorshub.advfn.com/boards/board.aspx?board_id=11403

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