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Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

inties, which include, without limitation, risks related to the uncertainty of the FDA approval process and other regulatory requirements, and the timing of completion of the steps necessary for resubmission of the NDA for AZ-004.  Alexza may be unsuccessful in resolving the issues in the CRL and it may never receive marketing approval for AZ-004 or any of its product candidates.  These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission including the risks under the headings: "Regulatory authorities may not approve our product candidates even if they meet safety and efficacy endpoints in clinical trials.", "We have a history of net losses. We expect to continue to incur substantial and increasing net losses for the foreseeable future, and we may never achieve or maintain profitability.", and "We will need substantial additional capital in the future. If additional capital is not available, we will have to delay, reduce or cease operations.".  Forward-looking statements contained in this announcement are made as of this date, and we undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


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Related medicine technology :

1. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
2. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
3. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
4. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
5. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
6. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
7. Alexzas Staccato® Nicotine Licensed to Cypress Bioscience
8. Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference
9. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
10. Alexza to Announce 2010 Second Quarter Financial Results on Monday, July 26, 2010
11. Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
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