leguaan3 schreef:
Saturday, 30 May 2009 04:22
Advanced Life Sciences (OTC:ADLS) has been on our radar screen for a few weeks as one of our Extreme FDA Trades, but it may continue to climb based on its pending New Drug Application for a once-daily antibiotic for the treatment of adults with mild to moderate community acquired pneumonia (CAP). It has a PDUFA decision date of 7/31/09.
The stock rose +42.42 % on Friday after getting good news from Food and Drug Administration scientists on Friday. Studies involving Advanced Life Sciences Holdings Inc.'s pneumonia drug revealed no unexpected safety concerns. Clinical studies involving the drug, Restanza, revealed safety concerns that are common with other types of pneumonia and bacterial antibiotics, including diarrhea, nausea and headaches, FDA scientists said.
The stock shot up from $.99 and reached a high of $1.60 on Friday as it continues to trade well above it's 50 day moving average. Before the close, the stock price settled at $1.41. Traders expect that the stock price will continue to climb on Monday, but the extreme price action could come on Tuesday as an FDA-sponsored panel of medical experts will discuss Restanza on that day. They could recommend whether to approve the drug, according to a report from the Wall Street Journal.
If approved, Restanza would treat patients over the age of 18 who suffer from community-acquired pneumonia. Roughly 1 million people over the age of 65 suffer from the infection annually, with symptoms that include fever and hypothermia. Infection can often result in death.
The company announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the June 2, 2009 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. At the meeting, the AIDAC will review and discuss Advanced Life Sciences' New Drug Application (NDA) for Restanza(TM) (cethromycin) in the proposed indication of outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP).
Briefing documents from FDA and Advanced Life Sciences can be found on FDA's website at
www.fda.gov/ohrms/dockets/ac/09/brief... According to those documents and medical reporters who have studied them, Restanza revealed "a mixed picture of effectiveness when compared to current antibiotics." In other words, while several studies showed Restanza was slightly better than current antibiotics, such as clarithromycin, other studies showed current treatments were more effective than Restanza.
Advanced Life Sciences is planning a conference call for the morning of Wednesday, June 3, to discuss the results of the June 2nd AIDAC Meeting. Additional call information will be forthcoming.
Advanced Life Sciences acquired the antibiotic in 2005 from Abbott Laboratories (ABT). Abbott studied the antibiotic from 1999 to 2002 but stopped developing it. The FDA said Abbott's studies don't provide much evidence for Restanza's effectiveness, but do contribute to the product's safety profile.
Biotech investors interested in subscribing to our complete database of Clinical Trials and upcoming FDA decisions can access that information at the link below:
biomedreports.com/component/content/a...Disclosure: No Positions