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Advanced Life Sciences Receives FDA Guidance on Approval Pathway for Restanza in Community Acquired Bacterial Pneumonia and Biodefense Indications
Date:3/11/2010

Advanced Life Sciences also announced that it received notice from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services that it has completed its initial technical evaluation of the Company's $15 million funding proposal for advanced development of Restanza as a biodefense countermeasure and identified it as a scientifically and technically sound proposal important to program goals and objectives that may require further development and may be recommended for acceptance subject to funds availability.  The Company was invited to submit additional information to allow BARDA to make a final determination on the appropriateness of the proposal to enter into contract negotiations.

Related to this development, Advanced Life Sciences also gained clarity from the FDA on the biodefense regulatory package required for submission in light of recent AIDAC meetings discussing the use of the FDA's Animal Rule for approval of biodefense therapeutics. As anticipated, the FDA recommended that, in parallel with pivotal animal studies demonstrating efficacy under FDA's Animal Rule, Advanced Life Sciences should complete the CABP clinical program and submit a complete response to the CABP new drug application (NDA) prior to submitting an amended NDA for the biodefense indications.

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SOURCE Advanced Life Sciences Holdings, Inc.
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