CHICAGO, Aug. 5 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS),
Highlights from The KonLin Letter include:
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, Restanza™, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including community acquired bacterial pneumonia (CABP) and biodefense pathogens including anthrax, plague and tularemia. In June 2010, the Company submitted a Special Protocol Assessment (SPA) with the FDA for the proposed Phase III clinical program of Restanza in the treatment of patients with CABP. The Company has been engaged in the SPA process with the FDA over the last year to establish the clinical trial design needed to gain approval in CABP. As filed, the updated SPA incorporates written and oral comments from the FDA's Division of Anti-Infective and Ophthalmology Products. Based on the FDA's review cycle, the Company expects a reply to its submission by mid-August of this year.
The opinions expressed in "The KonLin Letter" are those of the analyst and not of Advanced Life Sciences. Advanced Life Sciences does not accept responsibility for the accuracy of any of the information or statements contained in this report. For information provided by Advanced Life Sciences with respect to its business and business prospects, as well as associated risks with an investment in the Company's stock, please see the Company's reports filed with the Securities and Exchange Commission, copies of which are available at www.sec.gov.
For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
SOURCE Advanced Life Sciences Holdings, Inc.
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