related to lower clinical development and manufacturing costs associated
with the Company's lead product cethromycin.
* General and administrative expense. General and administrative expense
increased $0.2 million to $1.7 million for the three months ended
March 31, 2008. The increase was attributable to costs associated with
cethromycin national advisory board meeting costs and higher
compensation and benefit expenses.
Year-to-Date 2008 Achievements:
* Attended the FDA Anti-Infectives Advisory Committee meeting that
discussed non-inferiority margins in CAP clinical trials on April 1
and 2, 2008 and held a conference call to provide management's
understanding of the Advisory Committee meeting to investors on April 3,
* Conducted a meeting with FDA on April 7, 2008 to discuss the anticipated
NDA submission in CAP and provided a summary of the outcome to investors
via conference call on April 10, 2008;
* Released results of our successful thorough QT study of cethromycin;
* Provided regulatory updates to multiple potential partners and advanced
negotiations regarding the commercial development of cethromycin as a
treatment for CAP;
* Met with the national advisory board for cethromycin consisting of
thought leaders in the area of respiratory tract infections and
antibiotic therapies to confirm the regulatory and development strategy;
* Advanced the development of ALS-357: received approval from the
Northwestern University Institutional Review Board (IRB) of the protocol
for the planned Phase I/II melanoma program.
Remaining Objectives for 2008
* Submit NDA for cethromycin in CAP;
* Finalize negotiations with potential commercial partners for
|SOURCE Advanced Life Sciences Holdings, Inc.|
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