CHICAGO, April 10 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for its novel once-a-day oral antibiotic, cethromycin, to treat mild-to-moderate community acquired pneumonia (CAP).
"We are pleased with the outcome of the meeting because it allows us to remain on track with our NDA submission goal," said Dr. Michael T. Flavin, chief executive officer of Advanced Life Sciences. "In addition, we believe that achieving this milestone will enable our partnership discussions to continue toward a conclusion in a timely manner."
During the meeting, FDA officials agreed that the Company could submit the NDA for cethromycin to treat mild-to-moderate CAP based on the pivotal Phase 3 trial results previously reported. The FDA will review any submission the Company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.
Conference Call Details
The Company will host a conference call and live webcast today, Thursday, April 10, 2008, at 8:30 am (EDT). The focus of the call will be to discuss the planned NDA submission for the Company's novel once-a-day oral antibiotic, cethromycin, as a treatment for mild-to-moderate CAP.
The conference call will be webcast simultaneously over the Internet.
Please visit the Investor Relations section of the Advanced
|SOURCE Advanced Life Sciences Holdings, Inc.|
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