Labopharm, Inc. (DDSS)
An international, specialty pharmaceutical company focused on improving existing drugs by incorporating its proprietary, advanced controlled-release technologies.
Recs
The trazodone debacle has hurt the stock recently. However, I see potential in the sales of tramadol. I think with the FDA's recent statements about vicodin and percoset, that it could mean an increase in tramadol prescriptions. If all gets settled with trazodone and approval is granted, Labopharm would have two approved drugs on the market one dealing with pain and one treating depression. I like the upside.
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Upcoming FDA approval... The current expectation will drive in a lot of people by July 18.
If approved, it might go higher... atleast 5$
Recs
has a pending NDA for a rapid-onset formulation of trazodone (DDS-04A) filed through the 505(b)(2) pathway as a new formulation of an existing drug for the proposed treatment of major depressive disorder with an estimated PDUFA action date of 7/18/09 for a possible FDA decision.
Recs
With approval of their once daily tramadol in the US, and pending approval of trazadone, this company has moved from being a speculative position to one where a profit becomes realizable in the not so distant future. Time will tell if management can turn the corner (given their salaries, they should prove this ability quickly).
Overall, with a now proven track record of being able to get drugs approved by both the FDA, and EMEA, the company's prospects of survival improve dramatically.
Additionally they saw in the third quarter a 28% market share for Canada, and a 97% increase in market share in Europe over the previous year(Representing 44% of the market). These numbers should continue to improve in the 4th quarter. The product with out the US, was approved globally representing 55% of the world market for tramadol. Now include the US, and the company should be able to cover all of their R&D and G&A costs. Throw another approval or two on top, and you have a real pharmaceutical company.
In the interest of full disclosure, I have owned shares in Labopharm for more than 2 years.
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will get fda approval
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the stock is moving up first target 3.80 once is over 3.80 5.77 than see 7
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Going to go up more... (owned it before, forgot to add it in here)...
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FDA olive branch shows light at the end of the tunnel for DDSS.
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Distribution of Tramadol products in most of the country...(but USA).
Lot of cash at the bank will allow them to better distribuate their products.
Product (Trazodone)under development (phase III) to be distributed the same way Tramadol is. It's a 13 Billion market.
Recs
Stock is in a tailspin. Weak financials coupled with competitive pressures does not bode well for stock beating broader market indices.
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The recent sell off due to delayed FDA approval is overdone...they have a solid balance sheet, pipeline and expected future earnings growth. Should be a $6 stock today.
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Still valued much higher than the overreactionary drop to 3.04. Will work its way back up.
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Drug delivery and reformulation is a crowded sector and requires branded life cycle extensions for strategies to be profitable

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