| Advance Life Sciences (OTC:ADLS) Climbs Higher On News and Pending FDA Decision | | Print | |
| Written by Jamie Tera | ||||||||||||
| Saturday, 30 May 2009 04:22 | ||||||||||||
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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. 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 http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4425b1-00-FDA-index.htm. 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: Disclosure: No Positions BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section Add this page to your favorite Social Bookmarking websites           
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Comments (4)
beoX
said:
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Advanced Life Sciences (OTC:ADLS) has been on our radar screen for a few weeks as one of our 
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... " The stock rose +42.42 % on Friday after getting good news from Food and Drug Administration scientists on Friday. " This is not true, the company merely sold materials for coming meeting and they were UPLOADED on the FDA web so anybody can read them. Nothing more. Really good news. |
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Dr. Jay
said:
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... The statement is TRUE, it is good news that there were no unexpected safety concerns. " Studies involving Advanced Life Sciences Holdings Inc.'s pneumonia drug revealed no unexpected safety concerns." Safety was the main concern for many investors and with this out of the way the only other thing is effiecy and the data already shows that it is "non inferior" according to the FDA guidance. |
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M.E.Garza
said:
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... My credentials. Are as follows. Family Practice Physician for eight years. Four years in the Air Force as a Family Physician. I was head of Avian Flu and Vaccination Program in Area of Responsibility in Kuwait during some phases of IRAQI Freedom. I do not know much about the FINANCIAL SYSTEM or the STOCK MARKET. Though after following this stock for two years I have learned some. SO HERE ARE THE PROS for this ANTBX. 1) Effective against CAP. 2) Effective for prophylaxis of exposure to Anthrax. 3) No C.diff side effect like AVELOX and LEVAQUIN. (TRUST ME THIS IS A BIG DEAL. HAPPENS IN MY PRACTICE WAY TO OFTEN) 4) Probably more effective against Strep Pneumo than Zithromax, possibly BIAXIN. 5) No shown Hepatoxity. 6) No QT prologation like AVELOX and LEVAQUIN. 7) Once a day dosing. 8) High concentration in Lung tissues. 9) Effective against a broad Range of BIOTERRORISM AGENTS. CONS ( AND I MEAN THIS ) 1) COUSIN of the BLACK SHEEP of the FAMILY KETEK. 2) Possible Hangover with FDA from KETEK. HOWEVER KETEK is STILL APPROVED BY FDA but with BLACK BOX WARNING. PEOPLE FORGET THOUGH THAT LEVAQUIN AND AVELOX have black boz warning as well. I am less qualified in the following areas but this is what I KNOW ABOUT THE financial side. PROS- 1) Abbot will likely have to pay us something or we will not have to pay abbot 30 million at approval due to Abbot screwing up the Patent in INDIA. 2) low Market CAP, has a lot a room to move upward. CONS- we are broke. ALL IN ALL I GIVE US A 5 to 1 odds of success. ANd SUCCESS to me mean 4-7 dollar a share price in three months. |
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