Wednesday, June 10, 2009 11:09:52 AM
Sheff DD Biotech Special 6/10/09-DDSS $1.77 FDA Approval Pending (Nasdaq)- Strong Buy
1)Partnerships for Trazadone in USA. Seeking a partner upon FDA Approval
Major partnership already with Tramadol with Purdue Pharma (Maker of Oxycontin)
2)Approval of Trazadone (DDS-04A) on July 18th via a 505 for formulation change
(PDUFA date of 7/18/09)
http://www.labopharm.com/default.aspx?id=214
3) Phase III study published in A peer-reviewed journal providing evidence-based information to practicing clinicians. The poster, entitled Once-Daily Trazodone in Major Depressive Disorder: Double-Blind, Placebo-Controlled Study, concludes Labopharm’s trazodone formulation is an effective and well-tolerated treatment for MDD patients, which improves quality of sleep.
http://www.psychiatrymmc.com/
4) 49th Meeting of the New Clinical Drug Evaluation Unit (NCDEU) of the National Institute of Mental Health to be held from June 29 to July 2, 2009- Will present positive Phase III Data they submitted for Trazadone approval to the FDA
http://www.nimh.nih.gov/research-funding/scientific-meetings/recurring-meetings/ncdeu/index.shtml
Poster of Phase III Study to Appear at Scientific Meeting in Florida
Labopharm will present a poster discussing the results of the Phase III clinical trial of its novel trazodone formulation at the 49th Meeting of the New Clinical Drug Evaluation Unit (NCDEU) of the National Institute of Mental Health to be held from June 29 to July 2, 2009. The poster, entitled Once-Daily Trazodone in Major Depressive Disorder: Double-Blind, Placebo-Controlled Study, concludes Labopharm’s trazodone formulation is an effective and well-tolerated treatment for MDD patients, which improves quality of sleep.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6337663
Co-sponsored by NIMH and the American Society of Clinical Psychopharmacology (ASCP), NCDEU is a scientific meeting that brings together academic researchers involved in clinical trials, research pharmacists, clinicians and clinical staff, and investigators with the pharmaceutical industry. The NCDEU program includes presentations and information from the National Institute of Mental Health, ASCP, and the Food and Drug Administration (FDA).
5) DDSS one of only 7 FDA approvals left on the year!
http://seekingalpha.com/article/136045-vanda-pharma-an-extreme-fda-trade-that-paid-9-more-to-go?source=yahoo
6)Approval of Trazadone in other countries
7) Fiscal Q2 results 7/6/09 which will include U.S. Tramadol Sales
LABOPHARM FEBRUARY 2009 PRESENTATION
http://www.labopharm.com/docs/Labopharm%20Presentation%20February%202009%20-%20FINAL.pdf
1)Partnerships for Trazadone in USA. Seeking a partner upon FDA Approval
Major partnership already with Tramadol with Purdue Pharma (Maker of Oxycontin)
2)Approval of Trazadone (DDS-04A) on July 18th via a 505 for formulation change
(PDUFA date of 7/18/09)
http://www.labopharm.com/default.aspx?id=214
3) Phase III study published in A peer-reviewed journal providing evidence-based information to practicing clinicians. The poster, entitled Once-Daily Trazodone in Major Depressive Disorder: Double-Blind, Placebo-Controlled Study, concludes Labopharm’s trazodone formulation is an effective and well-tolerated treatment for MDD patients, which improves quality of sleep.
http://www.psychiatrymmc.com/
4) 49th Meeting of the New Clinical Drug Evaluation Unit (NCDEU) of the National Institute of Mental Health to be held from June 29 to July 2, 2009- Will present positive Phase III Data they submitted for Trazadone approval to the FDA
http://www.nimh.nih.gov/research-funding/scientific-meetings/recurring-meetings/ncdeu/index.shtml
Poster of Phase III Study to Appear at Scientific Meeting in Florida
Labopharm will present a poster discussing the results of the Phase III clinical trial of its novel trazodone formulation at the 49th Meeting of the New Clinical Drug Evaluation Unit (NCDEU) of the National Institute of Mental Health to be held from June 29 to July 2, 2009. The poster, entitled Once-Daily Trazodone in Major Depressive Disorder: Double-Blind, Placebo-Controlled Study, concludes Labopharm’s trazodone formulation is an effective and well-tolerated treatment for MDD patients, which improves quality of sleep.
http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=6337663
Co-sponsored by NIMH and the American Society of Clinical Psychopharmacology (ASCP), NCDEU is a scientific meeting that brings together academic researchers involved in clinical trials, research pharmacists, clinicians and clinical staff, and investigators with the pharmaceutical industry. The NCDEU program includes presentations and information from the National Institute of Mental Health, ASCP, and the Food and Drug Administration (FDA).
5) DDSS one of only 7 FDA approvals left on the year!
http://seekingalpha.com/article/136045-vanda-pharma-an-extreme-fda-trade-that-paid-9-more-to-go?source=yahoo
6)Approval of Trazadone in other countries
7) Fiscal Q2 results 7/6/09 which will include U.S. Tramadol Sales
LABOPHARM FEBRUARY 2009 PRESENTATION
http://www.labopharm.com/docs/Labopharm%20Presentation%20February%202009%20-%20FINAL.pdf
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