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#1
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DDSS Labopharm Inc. Here is my next longer term play that could produce some nice profits in the near future DDSS has an FDA date of Feb11 I will update on DDSS as we progress. GLTA
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#2
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A very nice day for DDSS + 10% This one has much more left in it over the next month or so imo I will be looking to add on dips Congrats to all who got in.
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#3
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DDSS nice place to add to positions here imo 2.36 + 1.72 % for the day Come join us in the chat room for more DDSS talk Guest logins are welcome and best of all it is 100% free. Click on the link below to join other DDSS traders.
http://www.stockplaysonline.com/visichat/ |
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#4
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Today provided some nice reloading opportunities for DDSS However i tried to fill at 2.28 and never got filled I guess im gonna have to pay the price tomorrow lol. Be sure to join us in the chat room by clicking on the link below and share your thoughts on DDSS.
http://www.stockplaysonline.com/visichat/ |
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#5
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LAVAL, QC, Jan. 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced it has settled the previously announced draw down of $1 million under its standby equity distribution (SEDA) with YA Global Master SPV Ltd. (YA). Under the draw down, Labopharm issued 482,165 of its common shares to YA at a price of $2.07 per common share, net of the applicable discount. (All currency figures are in Canadian dollars.)
In accordance with the terms of the SEDA, the common shares were issued at a discount of 5% to the volume weighted average price (VWAP) on the Toronto Stock Exchange over the ten consecutive trading days following Labopharm's notice of its intention to draw down on the SEDA on December 20, 2009. Following the completion of the issuance of shares to YA, Labopharm has 57,938,529 shares outstanding. In connection with the draw down, Labopharm has filed a prospectus supplement to its short-form base shelf prospectus and registration statement to qualify the shares issued to YA. Copies of the final short-form base shelf prospectus, registration statement and prospectus supplement have been filed with SEDAR (www.sedar.com) and EDGAR (www.sec.gov) or may be obtained upon request to the Labopharm contact information below. Securities Laws Matters Securities legislation in certain of the provinces of Canada provides purchasers with the right to withdraw from an agreement to purchase securities. This right may be exercised within two business days after receipt or deemed receipt of a prospectus and any amendment. In several of the provinces, the securities legislation further provides a purchaser with remedies for rescission or, in some jurisdictions, revisions of the price or damages if the prospectus and any amendment are not delivered to the purchaser, provided that the remedies for rescission, revisions of the price or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province. However, such rights and remedies will not be available to purchasers of common shares distributed under this prospectus because the prospectus will not be delivered to purchasers, as permitted under a decision document issued by the Autorité des marchés financiers on November 23, 2009. In several of the provinces, the securities legislation further provides a purchaser with remedies for rescission or, in some jurisdictions, revisions of the price or damages if the prospectus and any amendment contain a misrepresentation, provided that the remedies for rescission, revisions of the price or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's province. Such remedies remain unaffected by the non-delivery of the prospectus, as permitted under the decision document referred to above. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province for the particulars of these rights or consult with a legal adviser. About Labopharm Inc. Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S., Canada, the United Kingdom, major European markets and Australia. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. and Canada and the Company has initiated the European regulatory approval process for its third product, a twice-daily formulation of tramadol-acetaminophen. Labopharm also has a pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com. This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements. |
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#6
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We brought you this one at the first part of the month at the 2.28 area Things are shaping up nicely here currently trading at 2.61 Im pounding the table here gang as DDSS has an expected announcement coming soon.
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#7
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LAVAL, QC and PRINCETON, NJ, Feb. 3 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has approved OLEPTRO(TM) (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of the antidepressant trazodone, for the treatment of major depressive disorder (MDD) in adults. OLEPTRO(TM) utilizes CONTRAMID(R), Labopharm's clinically validated technology that controls the release of active substances within oral medications.
"OLEPTRO(TM) represents Labopharm's second CONTRAMID(R) technology-based product to receive FDA approval in just over a year," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are excited about the opportunity for OLEPTRO(TM) and are preparing the product for launch into the $11 billion-plus U.S. antidepressant market. We are working towards finalizing a commercialization path for OLEPTRO(TM) that will maximize the value of our product in this market." MDD is a common mental illness often characterized by a combination of social and somatic symptoms. It affects more than 14 million adults in the U.S. and is the leading cause of disability globally. OLEPTRO(TM) will offer physicians another therapeutic alternative for their MDD patients. "There's a large body of evidence demonstrating the efficacy of trazodone in the treatment of MDD," said Dr. Stephen Stahl, Adjunct Professor of Psychiatry, University of California, San Diego School of Medicine. "Labopharm has developed a novel formulation of trazodone that effectively treats depression and provides a tolerable adverse event profile." Labopharm is actively exploring several alternatives for the U.S. commercialization of OLEPTRO(TM). Such alternatives range from out-licensing the product to a distribution partner while retaining the right to some degree of co-promotion, through to a full co-promotion arrangement under which Labopharm would share the sales function with a partner. The Company currently expects to finalize the commercialization plan for OLEPTRO(TM) in the near term. Labopharm expects OLEPTRO(TM) to be available for prescription in the U.S. later this year, with specific timing for its launch to be determined within the context of the final commercialization plan. The Company believes it is well advanced in its preparations for the U.S. launch of OLEPTRO(TM). The Company has completed market research with physicians and third-party payors, developed a positioning and marketing campaign for OLEPTRO(TM), and finalized product manufacturing and packaging arrangements. About the OLEPTRO(TM) Pivotal Study An eight-week randomized, double-blind, two-arm, multi-centre study in patients with unipolar major depressive disorder demonstrated OLEPTRO(TM)'s efficacy as a treatment for depression. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the OLEPTRO(TM) group versus the placebo group. The results of this study, which are published in the May 2009 issue of Psychiatry, include the following: - Statistical significance was achieved for the primary endpoint (p value of 0.012). - The overall discontinuation rate in the study was 25 percent with 21 percent in the placebo group and 30 percent in the OLEPTRO(TM) group. - In the OLEPTRO(TM) group, four percent of patients discontinued treatment due to somnolence or sedation. "Our research in the clinical study leading up to FDA approval showed that OLEPTRO(TM) was well-tolerated and demonstrated a significantly greater improvement in the HAMD-17 primary efficacy end point over placebo," said Dr. David Sheehan, University Health Professor and Director of the Depression and Anxiety Disorders Research Institute, University of South Florida College of Medicine. "When given at the recommended daily dose range, OLEPTRO(TM) was an appropriate monotherapy for patients with MDD." Labopharm will conduct a post-approval pediatric study. The FDA has asked Labopharm to provide data from a long-term maintenance study and an additional in-vitro alcohol dissolution study. About Major Depressive Disorder Approximately two times more prevalent in women than men, MDD often co-exists with other illnesses. Research shows that only approximately 65 percent of individuals with MDD are diagnosed and, of those patients, 90 percent are treated with medication. Treating MDD with antidepressant medications is challenging for physicians because patient response to antidepressant drug therapy varies significantly. Research has shown that as many as 28 percent of patients being treated with antidepressants stop taking their medication within the first four weeks of treatment and as many as 44 percent stop within the first 12 weeks. Reasons for discontinuing antidepressant treatment can include suboptimal efficacy, the exacerbation of symptoms such as sleep disturbance, agitation, and sexual dysfunction, and adverse events such as weight gain. The FDA's decision represents the first regulatory approval for Labopharm's novel, once-daily formulation of trazodone. The formulation is currently under regulatory review in Canada. Important Safety Information About Treatment with OLEPTRO(TM) For more complete information about the use of OLEPTRO(TM), please see the FDA-approved Prescribing Information and Medication Guide which will be posted on the FDA website (http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/). Black Box Warning Warning: Suicidality and Antidepressant Drugs See full prescribing information for complete boxed warning Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. OLEPTRO(TM) is not approved for use in pediatric patients. Warning and Precautions - Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behaviour, or unusual change in behaviour, whether or not they are taking antidepressant medications. Patients should be monitored for clinical worsening and suicidality and for the appearance of any of the following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Families and caregivers should be alerted about the need to monitor patients. - The development of a potentially life-threatening serotonin syndrome, or neuroleptic malignant syndrome (NMS)-like reactions has been reported with antidepressants, and may occur with OLEPTRO(TM), particularly with concomitant use of other serotoninergic drugs. Treatment with OLEPTRO(TM) and any concomitant serotonergic or antidopaminergic agents, including antipsychotics, should be discontinued immediately and supportive treatment should be initiated. - A major depressive episode may be the initial presentation of bipolar disorder. Prior to initiating treatment, patients should be adequately screened to determine if they are at risk for bipolar disorder and monitored for mania/hypomania. OLEPTRO(TM) is not approved for use in treating bipolar depression. - Experience with administration of immediate-release trazodone products indicates that there may be an increased risk for QT interval prolongation. QT prolongation may lead to Torsades de pointes and even death especially in susceptible individuals, such as those with hypokalemia, hypomagnesemia, or a genetic predisposition to prolonged QT/QTc. - Patients with pre-existing cardiac disease may be at more risk for arrythmias. Concomitant administration of drugs that prolong the QT interval or that are inhibitors of CYP3A4 may increase the risk of cardiac arrhythmia in these patients. - Orthostatic hypotension and syncope have been reported in patients receiving trazodone hydrochloride. - Drugs that interfere with serotonin reuptake, including trazodone hydrochloride may increase the risk of bleeding events. Concomitant use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk. - Serious, sometimes fatal, reactions have been reported when serotonergic drugs are used in combination with monoamine oxidase inhibitor(s). Therefore, OLEPTRO(TM) should not be used concomitantly or within 14 days of monoamine oxidase inhibitors. - Rarely, cases of priapism can occur in men receiving trazodone. OLEPTRO(TM) should be used with caution in men who have predisposing conditions. - There is a risk of hyponatremia when taking antidepressants. Elderly patients may be at greater risk, as well as patients taking diuretics or who are volume-depleted. - OLEPTRO(TM) has the potential to impair judgment, thinking, and motor skills. Advise patients to use caution before driving and when operating machinery. - Discontinuation symptoms may occur with abrupt discontinuation, and may include anxiety, agitation and sleep disturbance. Upon discontinuation, taper OLEPTRO(TM) and monitor for symptoms. |
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