Discovery Laboratories, Inc. (NASDAQ:DSCO)
A biotechnology company, which develops its proprietary surfactant technology as Surfactant Replacement Therapies for respiratory disorders and diseases.
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crapshot with the fda - I see dsco at $3.5 in sept to $5 a year from now awaiting the fda decision. If ok stock catapults a dendreonic 15 pts. If turned down again dsco is 15 cents
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The company is poised to receive approvsl from the FDA on its Surfaxin product which is better than anyt other treatments currently on the market.
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picked this back in feb, have been watching it pretty close since and am intrigued by the 140000 shares bought by insiders this month. hmmmmm........
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this drug has taken over 2 years to come out. I think they may have gotten it right this time.
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Discovery is a biotechnology company developing its proprietary surfactant replacement therapies (SRT) for respiratory diseases. The company offers Surfaxin, a protein B-based agent for the prevention of respiratory distress syndrome in premature infants. It has developed a pipeline centered on surfactant, the protein and lipid mixture that coats the inside of the lung and makes breathing possible. It also offers its products for the treatment of acute respiratory distress syndrome in infants and adults in the intensive care unit, as well as a precision-engineered SRT used as an inhaled aerosol for patients suffering from asthma.
Surfaxin successfully completed two Phase II trials in neonatal respiratory distress syndrome in March 2006. Unfortunately, manufacturing deficiencies have continually delayed Surfaxin’s approval for which the US FDA has issued two separate approvable letters. Discovery expects to re-file Surfaxin’s new drug application (NDA) in late 2007 after resolving its manufacturing issues, suggesting a launch in mid 2008, if approved.
Further Discovery has voluntarily withdrawn the Marketing Authorization Application (MAA) for Surfaxin from the European Medicines Evaluation Agency (EMEA) in June 2006. Withdrawal precludes resolution of certain outstanding clinical issues, relating to the Surfaxin Phase III clinical trials, including the design and lack of comparison to Curosurf, the leading surfactant in Europe. As a consequence, additional clinical trials may be required to support approval of Surfaxin in Europe.
For the nine months ended September 2006, revenues were nil, down from $105,000 reflecting the absence of contracts and grants revenues from Chrysalis Technologies, its partner in commercializing SRT. In May 2006, the company announced a reorganized management and a 33% workforce reduction primarily affecting its commercial infrastructure. However, net loss also rose 30% reflecting a 17% increase in general and administration expenses and 12% increase in research and preclinical operations cost and a $4.8 million restructuring charge that the company incurred. There seems to be a bleak possibility to generate profits in the near-term, making Discovery an underperformer in the near-term.
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I expect FDA to approve Surfaxin soon.
Possible partnership with MO in manufacturing.
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my pick for the premies
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following downwithpumpers
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DSCO will meet with the FDA ON 12/21/2006 And they will give the approval and steps to put there drug on the market. Take that to the bank could see a run up in the stock before the FDA meeting.
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Biopharm company that has struggled with approval for a one-of-a-kind drug but now seems poised to deliver with FDA now ready to take another look.
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DSCO's treatment for RDS will be finally approved after manufacturing issues are resolved.
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poor management, manufacturing problems, will be sold.
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Makes lung surfactant replacement treatment (Surfaxin) for RDS. Currently a small market, however Surfaxin is a cheaper, safer version than currently available, which will likely increase usage of this type of treatment.
Had manufacturing problems that appear to be fixed.
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