of thought leaders in the area of respiratory tract infections and
-- Granted Orphan Drug Designation by the FDA for ALS-357 in the topical
treatment of metastatic melanoma; and
-- Advanced development of ALS-357: manufactured clinical supplies and
submitted the protocol to the Northwestern University Institutional
Review Board (IRB) for the planned Phase I/II melanoma program.
Cethromycin Objectives for 2008
-- Attend FDA Anti-Infectives Advisory Committee meeting discussing
non-inferiority margins in CAP clinical trials scheduled for
April 1 and 2, 2008 and provide management's understanding of the
Advisory Committee meeting to investors via conference call on
April 3, 2008.
-- Conduct meeting with FDA on April 7, 2008 to discuss the anticipated
NDA submission in CAP and provide summary of outcome to investors via
conference call on April 10, 2008.
-- Incorporate guidance from April 1-2 FDA Advisory Committee meeting and
April 7 Advanced Life Sciences meeting with FDA to complete NDA
submission activities for cethromycin as a treatment for CAP;
-- Finalize negotiations with potential commercial partners for
-- Continue collaborations with the National Institute of Allergy and
Infectious Diseases (NIAID) and The U.S. Army Medical Research
Institute for Infectious Diseases (USAMRIID) to explore cethromycin's
activity against high-priority bioterror agents for its use as a broad
spectrum countermeasure; and
-- Present cethromycin clinical data at ICAAC in the Fall.
Financial Guidance for 2008
Advanced Life Sciences expects its 2008 cash requirements excluding
milestone payments that become due upon NDA filing to f
|SOURCE Advanced Life Sciences Holdings, Inc.|
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