What happed to Advanced Life Sciences (OTC:ADLS)?

Calls and emails flooded in from subscribers holding shares of Advanced Life Sciences (OTC:ADLS). They wondered what the catalyst was for the stock price plunge- from $1.60 to $.25 on heavy trading Tuesday afternoon.

the FDA's Anti-Infective Drugs Advisory Committee was scheduled to meet to discuss

Restanza, a novel, once-a-day, oral antibiotic that is under review for approval by the FDA for the treatment of Community Acquired Pneumonia (CAP).

CAP is the sixth most common cause of death in the United States. It and other respiratory tract infections are caused by pathogens that affect 5.6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

So what happened? A company spokesman has sent a press release that indicating that the committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

As BiomedReport.Com's Jamie Tera reported this weekend, traders were expecting that the company's stock price would continue to climb on Monday (it did), but she also warned that extreme price action could come on Tuesday as the FDA-sponsored panel of medical experts would meet on that day. Some investors must not have been monitoring the progress of the advisory meeting as closely as others.

The stock ended up rebounding a bit from the day low. It closed at $.50 and is up a few more cents after hours.

"We believe in Restanza's potential and remain committed to its development. We were particularly encouraged by the supportive comments of several members of the committee relative to their positive review of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the company pursue further development," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "As we have throughout the review process we will continue to work closely with the FDA as they complete their assessment of the Restanza new drug application (NDA)."

Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP. The FDA has established a Prescription Drugs User Fee Act (PDUFA) date of July 31, 2009 for the Restanza NDA.

For those of you interested in knowing more, Avanced Life Sciences will host a conference call and live webcast at 8:30 a.m. Eastern Time on Wednesday, June 3 to discuss the outcome of the AIDAC Review.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 866.713.8567 (domestic) or 617.597.5326 (international). The passcode for the conference call is 15573457. A replay of the conference call will be available until July 10, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 27483036. Investors are advised to dial into the call at least ten minutes prior to the call to register.

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