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Zacks Investment Research @ NSPH
Some of this opinion could very well change with approval that could lead to partnership(s), new distribution channels.
Holding 1,000 shares and adding on dips!
Nanosphere Sales Growth In 2H 2009
By Brian Marckx
On Tuesday June 30, 2009, 2:55 pm EDT
Companies:Nanosphere, inc.
With the Verigene System and 2 currently approved assays not receiving approval until late-2007, Nanosphere Inc. (NasdaqGM: NSPH - News) currently generates little in the way of revenue relative to their cost base. We expect the company to generate negative operating income for the foreseeable future as SG&A and R&D expenses remain elevated to support newly-approved products and the company's pipeline.
Manufacturing efficiency programs and economies of scale through higher production volumes should benefit gross margins and help offset increased operating expenses. Grants and government contracts, which had provided 25% of revenue in 2008, will likely be immaterial in 2009 and beyond.
We expect the cystic fibrosis, HFE, Cardiac Troponin and next-generation RVP assays along with the Verigene SP system to receive FDA approval and launch in the second half of 2009. This should help drive significant revenue growth in 2009.
Longer-term growth expectations could significantly increase depending on the success of the Cardiac Troponin assay. We note that Nanosphere should be very diligent in getting its SP system to market as soon as possible in order to continue to grow its customer base, ramp sales of its assays and avoid customer attrition. We believe growing the customer base will be slow-going until the SP system is launched as customers will be hesitant to start with the legacy system, only to switch to the next-generation system shortly afterwards.
Cash position is healthy. At the current annualized cash-burn run-rate the company has enough cash reserves to operate for about 24 months, which could lengthen as additional product approvals come to market and sales growth outpaces that of operating expenses. The company is relatively conservatively capitalized. Amortization of the credit facility and capex requirements should be easily manageable for at least the next 2 years.
For 2009 we model sales of $4.25 million, up significantly from the $1.37 million posted in 2008. Revenue growth will be supported by increased utilization rates and the launch of several new assays and the next-generation Verigene system. A favorable decision by CMS relative to reimbursement of the warfarin test would provide some upside to our current financial forecast.
Risks to our forecast are delays in getting the new assays to market or a delay in commercializing the SP system, which could result in customer attrition and overall difficulty in growing the customer base.
We currently forecast revenue to grow at a CAGR of 71% from 2008 through 2012 but for net income to remain negative through that period. Positive net income should materialize in the next decade as the company is able to ramp sales and leverage its marketing/administrative and manufacturing bases. Research and development spending should moderate relative to sales and further improve operating margins.
Nanosphere shares currently trade at $5.32. We recommend that investors hold at the current price and forecast EPS loss of $1.64 in 2009. Our price target is $6.00.
NANOSPHERE INC (NSPH): Read the Full Research Report
Zacks Investment Research
Added more on the dip @ NSPH
500 shares @ $3.97
GLTA
Investor 100
Interesting Article @ Bio Markets
http://washington.bizjournals.com/washington/stories/2009/06/29/focus1.html?b=1246248000^1851349
Reading between the lines tells me that more partnerships are coming!
GLTA
Investor 100
CNN Health Response to Swine Flu in USA
http://www.cnn.com/2009/HEALTH/07/09/obama.swine.flu/index.html
Not sure if this might help HEB!
HEB up 14% today closing @ $2.28
Investor 100
Lots of MOMO!
Large buys the past 20 minutes!
GLTA
Investor 100
CNN News Article on Swine Flue Response
http://www.cnn.com/2009/HEALTH/07/09/obama.swine.flu/index.html
Hopefully CEO Carter has contacted the CDC!
GLTA
Investor 100
U.S. pledges $8.5 billion for fall swine flu shots
Vaccination program could begin in mid-October, top health official says
Video
$8.5 billion pledged in swine flu fight
July 9: The fight against swine flu gets an $8.5 billion boost from the U.S. government with a sweeping vaccine program set for the fall. NBC’s Dr. Nancy Snyderman talks with top health officials Kathleen Sebelius and Dr. Thomas Frieden.
Dr. Nancy
Swine flu outbreak video
WHO declares swine flu a pandemic
June 11: The World Health Organization declared the H1N1 swine flu a global pandemic, the first since 1968. Chief Science Correspondent Robert Bazell reports on what it means for the U.S., where the virus has been spreading for weeks.
WHO: Second wave of swine flu possible
Baby delivered, mom dies of swine flu
Swine flu kills 7 in New York City
Swine flu vaccine may be ready by October
WASHINGTON - Vaccinations against swine flu are likely and probably will begin in mid-October, assuming soon-to-start studies go well.
The government will fully pay for any autumn vaccination program against the new H1N1 swine flu, Health and Human Services Secretary Kathleen Sebelius said on Thursday.
"We have already appropriated about a billion dollars to buy the bulk ingredients," Sebelius told a swine flu "summit" of state and local leaders at the National Institutes of Health.
http://www.msnbc.msn.com/id/31828836/ns/health-swine_flu/
Investor 100
Interesting Article from Forbes @ DDSS
Nice volume and MOMO today!
http://www.forbes.com/feeds/afx/2009/07/06/afx6621218.html
GLTA
Investor 100
HOD @ HEB!
Lots of MOMO!
GL
Investor 100
Good morning fourkids!
So far not a bad day @ HEB!
Thanks for the stat's report!
Investor 100
Deep Down in Deep Sleep?
The press releases listed below offers some results and potential opportunities given new hires however the company has not reported any significant number of contracts!
Until that time DDI is stuck in neutral (IMO).
Me, in a holding pattern with DDI.
GLTA
Investor 100
------------------------------------------------------
In The Press
07/01/09 - Deep Down Expands Presence in Brazil
Deep Down, Inc., a global leader in offshore deepwater products and services for the oil and gas industry, today announced the engagement of Marcelo Lardosa as Business Development Officer.
05/14/09 - Deep Down Inc Announces First Quarter Results
Deep Down, Inc. announced today unaudited results for the first quarter ended March 31, 2009.
04/20/09 - Deep Down S-1 Registration Declared Effective
Deep Down, Inc. today announced that its registration statement on Form S-1, registering approximately 57 million shares of its common stock,
04/03/09 - Deep Down Expands Sales Organization
Deep Down, Inc.today announced it has expanded its sales organization to support the substantial growth the Company is experiencing.
03/24/09 - Deep Down Awarded Patent for New Subsea J-Plate Design
Deep Down, Inc. today announced that it has been awarded a patent [number 7,467,662 B2] by the United States Patent and Trademark Office.
03/19/09 - Deep Down Reports 84.5% Increase in Revenue
Deep Down, Inc. today commented on its results of operations for the year ended December 31, 2008, reported on Form 10-K and filed on March 16, 2009 with the Securities and Exchange Commission.
AH @ $2.18 (+9%)
GLTA
Investor 100
Thanks Sheff!
I have my playbook out tonight to take notes!
Cheers!
Investor 100
Buying on the dip @ NSPH!
500 shares @ $4.10 as the first step!
Thanks Sheff!
Investor 100
CFS Public Health Research Program Draft 5-year Strategic Plan
This document presents the CDC's CFS Public Health Research Program 5-year strategic plan, which takes into account the November 2008 Peer Review Panel's recommendations, comments during and following the April 2009 Stakeholders´ Meeting, and discussions with collaborators. In brief, the CFS Public Health Research Program´s primary aim is to reduce morbidity associated with CFS. Program strategy over the next 5-years will follow an interactive biosystems public health model with increasing emphasis on design, implementation, and evaluation of interventions to reduce morbidity associated with CFS. This document briefly:
1. Discusses current research program strategy, the interactive biosystems model upon which strategy is based, and current tactical components of the research program.
2. Outlines program´s 4 major goals and the logic model that serves as their framework.
3. Presents projected activities (milestones) associated with the program´s 4 goals.
On This Page:
1. CFS Public Health Research Program Strategy
2. Research Program Strategy Involved 3 Coordinated Complementary Tactical Components
3. CFS Public Health Research Program Goals
4. Research Program Strategy Involved 4 Coordinated Complementary Goals
5. CFS Public Health Research Program 5-year Activities & Milestones Associated with Goals
I. CFS Public Health Research Program Strategy
CFS is a complex illness representing alterations in multiple ecologically and biologically interrelated homeostatic systems. CFS is not the result of a single mutation or simple environmental factor but arises from a combined action of many genes, environmental factors (including infection) and risk conferring behavior; and, it is clinically heterogeneous and comprised of subtypes. Research Program strategy follows an interactive biosystems public health model as illustrated below. The next 5 years´ work will have an increasing emphasis on translational research, involving design, implementation, and evaluation of interventions to reduce the morbidity associated with CFS and to improve the quality of life of persons with the illness.
II. Research Program Strategy Involves 3 Coordinated Complementary Tactical Components
A. Population-based surveillance
1. Cross-sectional and prospective case-control studies of defined populations to:
1. Identify risk factors as related to clinical attributes (i.e., subsets) of CFS.
2. Identify psychosocial, clinical, and laboratory biomarkers associated with the clinical course of CFS and subsets of the illness (i.e., identify different triggering/perpetuating factors and associated subsets of the illness).
3. Evaluate effects of access to and utilization of health care and quality of health care on clinical course of the illness.
4. Determine knowledge/attitudes/beliefs concerning CFS, elucidate their effects on clinical course of the illness, and measure changes associated with educational interventions.
5. Evaluate direct and indirect economic impact of CFS.
6. Provide a source of well characterized participants for in-hospital clinical studies.
2. Health care provider based patient registries to:
1. Evaluate clinical attributes/clinical course of patients with CFS (and illness subsets) who are in different health care settings.
2. Provide data concerning efficacy of education efforts.
3. Provide a source of well characterized participants for clinical studies and treatment trials.
3. Data repository to further characterize CFS in relation to risk markers. This will involve collaboration with other investigators (i.e., data sharing).
B. Clinical and laboratory studies
1. Hypothesis testing in-hospital clinical studies to:
1. More precisely identify risk factors as related to clinical attributes (i.e., identify subsets).
2. Measure psychoneuroendocrinologic and immune system characteristics of CFS (i.e., identify subsets).
3. Elucidate pathophysiologic mechanisms (i.e., identify subsets).
4. Suggest therapeutic targets for various subsets of CFS.
2. Laboratory studies to:
1. Measure neuroendocrinologic, metabolic, immune and infectious characteristics of CFS (i.e., identify subsets).
2. Identify potential diagnostic and therapeutic targets for various subsets of the illness.
3. Identify pathophysiologic mechanisms associated with subsets of CFS.
4. Identify therapeutic targets.
5. Maintain a biorepository for in-house and collaborative molecular analyses.
C. Educational Intervention & Research
1. Educational Intervention
Educational intervention involves, on the most immediate level, providing current evidence-based information on diagnosis and management of CFS to health care providers, persons with CFS and their caregivers. On a broader scale it involves providing the most current evidence-based information concerning CFS to federal, state, and local public health authorities, related government agencies, and HMOs and building long-term relationships with government and non-government agencies.
2. Educational Intervention Research
Educational intervention research involves identifying barriers to health care utilization that can be targeted through providers, patients, caregivers, public health authorities, and HMOs. More importantly, it involves measuring outcomes associated with various intervention activities.
III. CFS Public Health Research Program Goals
The CFS Public Health Research Program conducts public health research leading to the control and prevention of CFS (and similar medically unexplained chronically fatiguing illnesses) and to improve the quality of life of persons with these illnesses. Goals associated with our 5 year vision for the program are to:
1. Refine our understanding of etiologic pathways involved in various CFS subgroups in order to improve diagnosis and to identify therapeutic targets.
2. Improve clinical management of CFS patients by developing and providing evidence-based educational materials that address evaluation, diagnosis and clinical management of CFS.
3. Improve diagnosis and management of CFS through basic research.
4. Move CFS into the mainstream of public health concerns.
Program strategy has successfully focused on obtaining baseline information necessary to plan clinical and educational interventions and to quantitatively/qualitatively measure outcomes associated with intervention efforts. Strategy over the next 5-years will focus on 4 translational research goals to plan, implement and evaluate clinical, educational and public health interventions, and to measure associated outcomes. Many of the Peer Review Panel´s comments and comments offered by Stakeholders reflected parallel thinking.
IV. Research Program Strategy Involves 4 Coordinated Complementary Goals
A. Goal 1: Refine understanding of the etiologic pathways involved in CFS in order to improve diagnosis and to identify therapeutic targets.
1. Identify psychosocial, clinical, and laboratory biomarkers associated with the clinical course of CFS and subsets of the illness.
2. Identify risk factors as related to clinical attributes (i.e., subsets of CFS).
3. Measure neuroendocrinologic, metabolic, immune and infectious characteristics of CFS to identify potential diagnostic and therapeutic targets for various subsets of the illness.
4. Elucidate pathophysiologic mechanisms associated with symptoms and subsets of the illness.
5. Develop collaborative data sharing networks to extend knowledge concerning CFS.
B. Goal 2: Improve clinical management of CFS patients by developing and providing evidence-based educational materials that address evaluation and clinical management of CFS.
1. Develop international consensus regarding diagnosis of CFS in clinical and research settings (i.e., research, clinical, pediatric/adolescent case definitions).
2. Develop international consensus regarding management of CFS and future research direction.
3. Provide current evidence-based information on diagnosis and management of CFS to health care providers, persons with CFS and their caregivers, and evaluate associated outcomes.
4. Evaluate effects of access, utilization, and quality of health care on clinical course of the illness.
C. Goal 3: Improve diagnosis and management of CFS through basic research.
1. Collaborate to establish an international CFS research network.
2. Collaborate to conduct clinical intervention trials.
D. Goal 4: Move CFS into the mainstream of public health concerns.
1. Develop collaborations with national, state and local public health authorities.
2. Provide current evidence-based information concerning CFS to federal, state, and local public health authorities, related government agencies, and HMOs.
3. Evaluate outcomes associated with dissemination of public health information.
V. CFS Public Health Research Program 5-Year Activities & Milestones Associated with Goals
A. Workshops and International Research Networks
1. International Workshop - Clinical Management of CFS
The aim of this workshop (to be held summer 2009) is to establish a collaborative international consortium of investigators who will present and discuss evidence- and practice-based findings related to the treatment, and management of CFS. Our aim is to produce published management guidelines that are applicable to practicing health care professionals in the treatment of CFS and to establish a network of investigators, clinicians, and others who will meet regularly to discuss clinical management issues pertinent to CFS and related illnesses.
Addresses Goal 2 (B.2)
2. International Workshop - CFS Case Definition
CFS is defined by symptoms and disability, has no confirmatory physical signs or characteristic laboratory abnormalities, and the etiology and pathophysiology remain inchoate. Difficulties with accurate case ascertainment contribute to this ignorance. To help resolve this, CDC convened an International CFS Study Group, which met in 2000, 2001, and 2002 and in 2003 published recommendations to guide systematic and reproducible application of the case definition. The Study Group´s recommendations have been criticized as too cumbersome for routine use in clinical practice and there is a need for current international consensus as to status of the published 2003 Study Group recommendations and as to an appropriate CFS case definition for health care providers. In 2010 CDC will convene an international workshop to discuss research and clinical CFS diagnostic criteria for adults and children and will produce published guidelines as to diagnostic criteria.
Addresses Goal 2 (B.1)
3. Workshop International - CFS Study Group
The illness CFS is clinically heterogeneous and likely comprised of subtypes representing various behavioral, genetic, environmental, and infectious factors and different biological pathways. To begin the process of developing collaborative research and data sharing networks, we will initiate another series of International CFS Study Group workshops to critically assess current clinical and empirical knowledge concerning the pathophysiology and heterogeneity of CFS and identify research priorities and to discuss issues such as common data elements, data collection techniques, and data sharing. Planning of this meeting and selection of participants will draw heavily upon experience from the 2 workshops discussed above. We anticipate that the International CFS Study Group will meet in 2010.
Addresses Goal 3 (C.1) and Goal 1 (A.5)
B. Population-based Surveillance
1. First Follow-up Study of CFS and Chronic Unwellness in Georgia.
Field work on the First Follow-up Study of CFS and Chronic Unwellness in Georgia will be completed by July or August, 2009. Approximately 80% of those who participated in the Baseline Survey of CFS and Chronic Unwellness in Georgia have participated in the follow-up. Analysis, interpretation, and presentation of findings will occur through early 2011. Initial analyses (currently approved by IRB review) will focus on:
1. Associations between medical history/exercise patterns/tobacco use and CFS.
2. Illness perception as related to clinical management of persons with CFS and their associations with clinical course of illness.
3. Sense of community/illness perception/illness management/help seeking behavior among those with CFS and their associations with clinical course of illness.
4. Interaction of sense of community/depression/and health related quality of life.
5. Refined analysis of allostatic load, cortisol, alpha amylase, inflammation index, and genetics of CFS.
6. Association of barriers to healthcare utilization with illness course.
7. Associations of self-reported sleep disorders and occurrence with clinical course of CFS.
8. Incidence of metabolic syndrome and diabetes in those with CFS and various comparison groups.
9. Occurrence of other adverse health events in those with CFS and various comparison groups. Focus of initial analyses will be on information that can be used to modify provider education activities.
Addresses Goal 1 (A.1, A.2, A.3, A.4). A.5 Goal 2 (B.1, B.4) Goal 3 (C.1, C.2, C.3) Goal 4 (C.1, C.2, C.3)
2. Second Follow-up Study of CFS and Chronic Unwellness in Georgia
The CDC cohort study in metropolitan, urban, and rural Georgia is unique in terms of resources and data and has been highly productive in terms of measurable output and outcomes, as was noted by the Peer Review Panel. Field work on the Second Follow-up Study of CFS and Chronic Unwellness in Georgia will begin in early 2010; will continue into 2011; and, analysis, interpretation and presentation of results will continue through 2012. The Second Follow-up Study will explore associations over a 5-year period between clinical parameters, laboratory biomarkers, psychosocial, and environmental factors and risk of incident CFS, persistent or progressing CFS, and recovery from CFS; this will also help to identify defined subsets of persons with CFS. The Second Follow-up Study will also measure the contribution of electrophysiologically identified sleep disorders to CFS and to the clinical course of the illness. Information from the Second Follow-up Study will be used to modify provider education activities, to evaluate effects of education activities, and to plan intervention trials. The Second Follow-up Study will also measure effects of the current economic crisis on the occurrence and clinical course of CFS.
Addresses Goal 1 (A.1, A.2, A.3, A.4). A.5 Goal 2 (B.1, B.4) Goal 3 (C.1, C.2, C.3) Goal 4 (C.1, C.2, C.3)
3. Collaboration with Mayo Clinic Rochester Epidemiology Project
The goal of the collaboration with the Mayo Clinic is to utilize medical records from the Rochester Epidemiology Project to study risk factors associated with the incidence of CFS and clinical course of the illness in the population of Olmstead County. This retrospective study will allow us to categorize risk factors associated with CFS. Work will begin in 2009 with analysis, interpretation and publication/dissemination of the data occurring through 2011.
Addresses Goal 1 (A.1, A.2, A3) Goal 3 (C.1, C.2) Goal 4 (D.2).
4. Bibb County CFS Pilot Patient Registry - Initial Enrollment
The initial round of patient recruitment will be completed by December, 2009. Analysis, interpretation, and presentation of findings will occur through late 2010. Focus of initial analyses (approved by IRB review) will concern:
1. Our initial aim of identifying the most efficacious and efficient manner of identifying screening and enrolling patients.
2. Identifying clinical differences between patients enrolled through the registry and persons with CFS identified the population-based studies.
3. Identifying issues to concentrate on in provider education.
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.2, B.3, B.4) Goal 3 (C.1, C.2) Goal 4 (D.1, D.2, D.3)
5. Bibb County CFS Patient Registry - First Follow-up
A major goal of the pilot patient registry is to evaluate the efficacy and efficiency of 2 study designs for identifying, screening, and enrolling a large number of well characterized patients into a longitudinal registry and then following them longitudinally to evaluate clinical course, outcomes of intervention protocols, and to provide well characterized participants for clinical studies. We anticipate that early in the analysis of data from the pilot registry we will modify enrollment and longitudinal follow-up procedures to be compatible with larger scale regional registry efforts. First follow-up and modification of patient registry activities will occur though FY 2012. In 2013 we will consider a provider registry in another region of the country (based on outcomes of this registry and international workshops). The Registry will form the nidus of educational and clinical trial intervention studies in 2011/2012. These educational intervention studies will serve as proof of concept for extension to other areas of the country
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.2, B.3, B.4) Goal 3 (C.1, C.2) Goal 4 (D.1, D.2, D.3).
C. Clinical Studies, Laboratory Studies
1. Pathophysiologic Mechanisms of CFS: Neuroimaging, Neuroendocrinology, Genomics
This 3-day in-hospital study with Emory University was discussed in detail during the peer review and was highly praised. Field work will be completed in June, 2009; analysis, interpretation, and presentation of findings will occur through early 2011. Focus of initial analyses (approved by IRB review) will concern:
1. Brain regions associated with the cognitive deficits manifested by persons with CFS.
2. Neural circuits involved in CFS associated interoception.
3. HPA axis, autonomic nervous system, immune system, and neuroendocrine system function during stress.
4. Genetic and epigenetic covariables associated with a through c above.
5. Identify pathophysiologic/clinical subsets presenting as the illness CFS.
Information obtained from this study will also be discussed during the international workshops (detailed above) and will be integrated into protocols for population cohort studies, into provider education activities, and will be utilized for planning clinical intervention trials.
Addresses Goal 1 (A.2, A.3, A.4, A.5) Goal 2 (B.1, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
2. Laboratory Studies
All CFS research activities include a laboratory component. Laboratory studies help to clarify associations of behavioral and environmental risk factors with clinical and psychosocial attributes of CFS, to identify subsets of the illness CFS, and to identify potential therapeutic targets. Current laboratory studies measure neuroendocrine function, immune function, genetics, epigenetics, and gene expression. Laboratory studies will remain tightly integrated with all program activities through the next 5-years, and will be modified as appropriate. In addition to integration with specific protocols, aliquots of biological specimens (saliva, serum, plasma, peripheral blood mononuclear cells, DNA and RNA) collected during population and clinical studies are maintained in an anonymous biorepository linked to epidemiologic, survey, and clinical data. Exploration of the contribution of specific pathogens including potential infectious agents and/or reactivation of latent infections (e.g. HHV-6) will also be pursued through relevant collaborative relationships. Finally, metabolic derangements including alterations in glucose metabolism and oxidative stress will be investigated.
Addresses Goal 1 (A.1, A.2, A.3, A.4, A.5) Goal 2 (B.1, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
3. Clinical Intervention Studies
Early appropriate clinical intervention effectively reduces the morbidity associated with CFS and similar illnesses. Clinical intervention studies will initially involve currently accepted modalities (e.g., cognitive behavioral and graded exercise therapy); we also anticipate developing pharmacologic intervention studies. Intervention studies will address changes in morbidity of persons with various CFS endophenotypes (identified through field, in-hospital, and laboratory studies discussed above). In addition to direct clinical intervention protocols, intervention studies will involve a substantial provider education effort (discussed below). Intervention studies will occur through the next 5-years and will assume increasing attention through that time.
Addresses Goal 1 (A.3, A.4) Goal 2 (B.2, B.3) Goal 3 (C.1, C.2) Goal 4 (D.2).
a. Clinical Behavioral Intervention Studies
Clinical behavioral intervention studies (conducted in collaboration with Emory University School of Medicine, the Bibb County Medical Society, Mercer School of Medicine, Mayo Clinic, and UK National Health Service) will evaluate cognitive behavioral therapy and graded exercise, and will utilize participants from the provider registry. We will develop protocols and select participants based on outcome of the international workshop on CFS treatment and management (discussed above) and information from ongoing studies of CFS. We plan to stratify impact of intervention by various parameters (e.g., duration of illness, onset type, early life stress, psychiatric comorbidity, cortisol responsiveness, fMRI changes). Selection of stable parameters for outcome measures comprises one of the largest challenges to evaluating the impact of intervention and this is a workshop topic. We anticipate that protocol development for these initial behavioral intervention studies will occur through 2010 and that conduct of these studies will likely occur through 2011/2012.
b. Pharmacologic Trials
Pharmacologic trials, as appropriate, will be based on outcomes of the Emory GCRC study, and the evolving CFS evidence-base. We have initiated discussions with several pharmaceutical companies and collaborators at Emory, Case Western Reserve, and Harvard concerning pharmacological intervention trials targeting pathophysiologic pathways involved in CFS.
D. Educational Intervention & Research
1. Educational Intervention will continue and will evolve through the next 5-years.
a. CFS Website
A major CFS Research Program activity involves providing evidence-based information to the public and to providers; to assuring that the information addresses their current concerns; and, to providing the information in a readily accessible format. We do this through the CDC CFS website. Based on statistical and data mining analysis of website utilization patterns, we are designing a new website, which will be operational in 2009. We will continue detailed analysis of public and professional needs and web utilization and anticipate two additional major revisions of the website through FY 2013. Between major revisions, iterations of the website will be updated as needed, considering evolution of the CFS evidence-base. As part of the 5-year plan, CDC will explore links with state/city health department websites and other websites such as Medscape and WebMD.
Addresses Goal 2 (B.3) Goal 4 (D.1, D.2, D.3).
b. CFS Provider CME
We anticipate continuing the CME component of provider education for primary care physicians, nurse practitioners, physician assistants, and allied health professionals through the next 5-years. In 2009 we plan on revising the current courses based on:
1. Outcomes of the international workshop on CFS treatment and management.
2. Statistical and data mining analysis of CME website utilization patterns data concerning utilization of the existing courses.
3. National surveys of provider knowledge, attitudes, and beliefs.
4. The changing evidence-base concerning clinical, research, and treatment.
In 2011 (based on ongoing analyses) we anticipate designing and implementing a more focused set of CFS continuing education courses.
Addresses Goal 2 (B.3) Goal 4 (D.2, D.3).
c. Pilot Health Care Provider Education/Intervention
Partnerships formed with healthcare providers participating in the patient registry provide an opportunity to conduct a focused community health care provider education/intervention study and data collected as part of cohort surveillance and the longitudinal registry will allow us to evaluate outcomes. Based on recommendations from the international workshop on CFS treatment and management (to be held summer 2009), we will design and implement a health care provider education/intervention study in Bibb county, which will occur through FY 2010. Analysis and interpretation of findings and their dissemination will occur through 2011 and we anticipate will be extended through 2013.
Addresses Goal 2 (B.3, B.4) Goal 4 (D.2, D.3).
d. New Relationships with Public Health Agencies
We are engaging CSTE and state and local health departments in the development of a CFS toolkit and orchestrate its dissemination to public health agencies. Health departments use such toolkits for a variety of public health problems. Over the next 5-years a major component of our translational public health medicine effort will involve engagement with national public health practice organizations, state and local health departments, and HMOs.
Addresses Goal 4 (D.1, D.2, D.3).
2. Education Intervention Research
Educational intervention research involves identifying barriers to health care utilization that can be targeted through providers, patients, caregivers, public health authorities, and HMOs. More importantly, it involves measuring changes associated with various intervention activities, which have little utility as mere exercises without associated outcome measures. Educational intervention research activities (discussed in all the preceding sections) form an integral part of population cohort surveillance, patient registries, and specific educational interventions.
Addresses Goal 2 (B.3, B.4) Goal 4 (D.2, D.3).
Page last modified on May 29, 2009
US Food and Drug Administration Link
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.MonthlyApprovalsAll
Drugs approved thus far in July.
GLTA
Investor 100
Swine flu commercial: Prime Minister tells Japanese people to remain calm
http://www.japanprobe.com/?p=10440
Looks as thou the media is spreading the word in Japan..need a translation thou!
GLTA
Investor 100
News Release
FOR IMMEDIATE RELEASE
Friday, July 3, 2009
Contact: HHS Press Office
(202) 690-6343
MEDIA ADVISORY: The White House Announces H1N1 Flu Preparedness Summit
WASHINGTON-The White House today announced that Health and Human Services Secretary Kathleen Sebelius, Homeland Security Secretary Janet Napolitano, Education Secretary Arne Duncan, and Homeland Security Advisor John Brennan will host an all-day H1N1 Flu Preparedness Summit with states to further prepare this nation for the possibility of a more severe outbreak of H1N1 flu. The Summit will be held on July 9, 2009 at the Natcher Conference Center at the National Institutes of Health in Bethesda, Maryland.
WHO: Kathleen Sebelius, HHS Secretary
Janet Napolitano, DHS Secretary
Arne Duncan, Education Secretary
John Brennan, National Security Advisor
WHAT: H1NI Flu Preparedness Summit
WHEN: Thursday, July 9, 2009 at 8:30 a.m.
WHERE: Natcher Conference Center Auditorium (Bldg. 45)
National Institutes of Health
9000 Rockville Pike
Bethesda, Md. 20892
The H1N1 flu virus continues to circulate in this country and in at least 100 other countries around the world - especially in the Southern Hemisphere, where flu season is underway.
"Scientists and public health experts forecast that the impact of H1N1 may well worsen in the fall - when the regular flu season hits, or even earlier, when schools start to open - which is only five or six weeks away in some cases," Secretary Sebelius said. "The goal of the Summit is to launch a national influenza campaign by bringing federal, state and local officials, emergency managers, educators and others together with the nation's public health experts to build on and tailor states' existing pandemic plans, share lessons learned and best practices during the spring and summer H1N1 wave, and discuss preparedness priorities."
"The federal government remains vigilant and well coordinated with state, local, and international partners as we prepare for all possibilities as to how the H1N1 flu virus may impact us this fall,"said Secretary Napolitano.
"Prevention is everyone's business. Parents, children, teachers, school leaders, communities, government and businesses, we need do our part individually and collectively prevent the spread of the flu virus," said U.S. Secretary of Education Arne Duncan. "We are emphasizing safety and the need to continue learning. We will continue following guidance from the Centers for Disease Control and Prevention and encouraging schools and districts to be in close communication with their local public health authorities and political leadership."
###
Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.
Last revised: July 03, 2009
Good morning @ HEB!
GLTA
Investor 100
Morning Sheff!
Lets make it a great day!
Investor 100
PPS Up in AH Trading @ HEB
$2.53 (+0.18 / +7.66% )
Nice MOMO for tomorrow!
Investor 100
PPS Up in AH Trading @ DDSS!
AH: $2.65! ( +.09 / 3.52% )
MOMO for tomorrow (IMO)
Investor 100
Updated NewBiomedicine Report @ DDSS
http://www.newbiomedicine.com/Revere/UploadFiles/file/DDSS%20Trazodone%20Contramid%20FDA%20Approval.pdf
GLTA
Investor 100
US Food and Drug Administration Link
http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Reports.MonthlyApprovalsAll
Updated link on drug approvals @ FDA
Investor 100
U.N. chief: $1 billion needed against swine flu
WHO wants a stockpile of vaccines for 49 of world's least developed nations
Associated Press July 6,2009
GENEVA - The United Nations may need more than $1 billion this year to help poor countries fight the swine flu pandemic, the world body's Secretary-General Ban Ki-moon said Monday.
"The funding has not been flowing as we have been expecting," Ban said. "We are now mobilizing all resources possible."
The money is needed to ensure the poorest countries get vaccine supplies and antivirals if the global epidemic continues to spread, he told a news conference.
World Health Organization chief Margaret Chan told the donors that she wants to mobilize a minimum stockpile of vaccines to 49 of the world's least developed countries as a first step. She did not name the countries.
"Many of the developing countries have weak health systems," said Chan. "They actually go into this pandemic what I call empty-handed. They don't have antivirals. They don't have vaccines. They don't have antibiotics."
The swine flu outbreak has been relatively mild so far and most people recover without taking antivirals, but Ban said it should not be taken for granted that the outbreak will continue to be mild.
Those fighting health issues vulnerable
Health officials are concerned that people in poorer countries and those fighting other health problems like malaria, tuberculosis, malnutrition and pneumonia might be more susceptible to swine flu.
"For the remainder of this year, it is our estimate that we may need ... over $1 billion," Ban said, without elaborating.
But speaking to donor countries later Monday, Ban said he counted on their support for funding.
"Public funding should come first before we ask for any private fundings," he told government officials.
The United Nations in May asked vaccine producers to reserve a portion of their pandemic vaccine production for poor countries, but has yet to make a specific appeal for general donations.
Some companies have agreed to help. GlaxoSmithKline PLC offered to donate 50 million doses of pandemic vaccine to WHO for distribution to developing countries.
Chan said she estimated that covering about 5 percent of a country's population would be reasonable for vaccine stockpiles to make sure that doctors, nurses and other health care workers are protected. Like Ban, she gave no detailed cost estimates.
"We hope to mobilize some funds to procure commodities, including antibiotics, antivirals and vaccines to countries," Chan said.
More than 94,000 infected
Some 429 people have died of swine flu and over 94,000 have been infected, according to the latest totals by the WHO. But experts fear the number of infected people may be much higher than those confirmed.
Last week, Britain's health minister said the country faces a projected 100,000 new swine flu cases a day by the end of August. Britain is the hardest-hit nation in Europe amid the global swine flu epidemic.
Chan warned governments that the pandemic "could have a devastating impact in the developing world" and urged countries to improve their health systems.
At an EU health conference, Sweden's health minister said Monday that countries must prepare for a second wave of infections that could be deadlier than the current outbreak.
There is a risk the virus could change its character and spread rapidly as European children return to school after summer holidays, Maria Larsson said at the meeting in Jonkoping, Sweden.
British health authorities said Monday that a 9-year-old who had "serious underlying health problems" died after contracting swine flu.
Excellent Read @ BDSI
http://www.newbiomedicine.com/Revere/UploadFiles/file/BDSI%20Onsolis%20FDA%20Approval_.pdf
GLTA
Investor 100
Thanks Sheff!
Also added my name to your list for keepsake!
Investor 100
Labopharm CEO Sees Trazodone Pact After FDA Decision >DDSS
July 6,2009 4:00pm
By Andy Georgiades
Of DOW JONES NEWSWIRES
TORONTO (DOW JONES)--Labopharm Inc. (DDSS) has made a great deal of progress in partnership talks for its Trazodone drug, but it sees no reason at this point to sign a deal until a U.S. regulatory decision is made, its top executive said.
In an interview with Dow Jones, James Howard-Tripp said that, with only two weeks to go until the U.S. Food and Drug Administration makes a decision, there would be "no logic" in finalizing a marketing pact now.
The FDA is expected to make a decision by July 18.
"With most groups, once you get to within a couple of weeks of the (FDA's deadline) date, (they're) probably a little reluctant to sign," he said, adding that Labopharm would also prefer to wait.
Assuming a positive decision, Labopharm would want to complete the partnership "fairly rapidly" after approval, with the aim of launching the drug "very early" in 2010, he said.
Trazodone has many generics available, but Labopharm's version is taken only once daily and can help patients sleep better.
Labopharm's stock has been on a tear, up 28% in July alone, mainly on anticipation of a regulatory decision on Trazodone and/or a partnership.
Canaccord Adams analyst Neil Maruoka said in a note Monday that he believes Trazodone has a "better-than-average" approval chance.
"A positive decision would likely result in a pop in the stock and point to a potential partnership for the drug in the near-term," he wrote. He rates the stock a buy.
On Nasdaq Monday, Labopharm is up 7 cents to $2.53 on 980,000 shares.
Company Web Site: http://www.labopharm.com
Excellent Read @ DDSS
http://www.newbiomedicine.com/Revere/UploadFiles/file/DDSS%20Trazodone%20Contramid%20FDA%20Approval.pdf
GLTA
Investor 100
Bought on the Dip @ DDSS!
Got the dip I needed to get into DDSS 5k @ $2.58.
Lots of MOMO on this pick Sheff!
Investor 100
Great Start for Monday Sheff!
Gotta like the solid run this morning @ DDSS!
Investor 100
Good morning Sheff & Sheff Station!
Good trades to all this week!
Investor 100
Opinion on Nanosphere Inc. (NSPH)
Healthcare Catalyst Stocks for 1H09
Healthcare Catalyst Stocks for 1H09
Below are four companies I have not written about recently with expected catalysts in the first half of 2009 in the form of FDA decisions or clinical trial results.
FDA Calendar of New Product Decisions
Last Fall, Discovery Labs (DSCO) received word from the FDA that its complete response for Surfaxin was accepted, but the six-month Class II review designation means that the decision date is pushed out to mid-April. DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in share price from current levels around $1.20 as the decision date nears. If DSCO experiences the bump in price, simply let the profits ride through the decision or just book all of the gains for a lower risk, lower reward trade on the expected increase in share price volatility heading into mid-April.
Emerging Diagnostic Index
Just before year-end, Electro-Optical Sciences (MELA) announced that the algorithms for analysis of the MelaFind pivotal trial were finalized with results expected to be released in several weeks. MelaFind involves a hand-held imaging device that emits light of multiple wavelengths to capture images of suspicious pigmented skin lesions and extract data for the early detection of melanoma, which is the most dangerous type of skin cancer.
Nanosphere (NSPH) recently filed 510(k) applications with the FDA for two new diagnostic products, including a cystic fibrosis assay and an infectious disease panel for respiratory viruses (influenza + respiratory syncytial virus or RSV). Since the 510(k) process is not as involved or length as a PMA; NSPH could receive word from the FDA by mid-2009.
NSPH trades at a market cap of $117M with a much lower enterprise value of $50M thanks to $75M in net cash on the balance sheet, but the Company is still in the early stages of transitioning from the development stage with just over $1M in trailing 12-month revenue. The Company is also developing additional diagnostic assays to detect cardiovascular disease (cariac troponin I test) and diagnostics should be the beneficiary of a focus on preventive medicine by the new administration.
Emerging Bio-Pharma Index
Synta Pharma (SNTA) is up over 35% in the past month thanks to a collaboration with Roche (RHHBY) for the development of anti-inflammatory drugs and the anticipation of Phase 3 clinical trial (SYMMETRY) results for elesclomol in the treatment of metastatic melanoma. Synta will receive $25M upfront with the potential to receive $245M in development milestones for the first product, a maximum of $122.5M each for the second + third products, and sales milestone payments up to $170M for each of the three products. Synta is also eligible for sales milestone payments up to $170M for each of the three products.
http://www.socialpicks.com/ideas/show/242421
Nanosphere to Release Three Abstracts At American Society of Clinical Oncology (ASCO) 2009 Annual Meeting
Northbrook, IL | Posted on May 28th, 2009
Abstract Title: "Ultra-Sensitive detection of biomarkers and applications in pharmaceutical discovery and development. Example application to rat Cardiac troponin I assay via nanoparticle probes."
Verisens(tm) cTnI Cardiotoxicity Assay is an in vitro diagnostic assay for the high-sensitivity detection and quantification of rat cardiac troponin I (cTnI). The assay is intended to be performed as a testing service for research use only.
For additional information, please contact Nanosphere at cardiotoxicity@nanosphere.us
Abstract ID: e16146 - Published: May 14, 2009, 6:00 p.m.
Abstract Title: "Detection of prostate cancer recurrence using an ultrasensitive nanoparticle-based PSA assay."
Verisens(tm) PSA is an in vitro diagnostic assay for the high-sensitivity detection and quantification of prostate specific antigen (PSA). The assay was developed in collaboration with the International Institute for Nanotechnology at Northwestern University. It is intended to be performed as a testing service for research use only (see research-use notification below).
For additional information, please contact Nanosphere at psa@nanosphere.us
Abstract ID: e22222 - Published: May 14, 2009, 6:00 p.m.
Abstract Title: "Biomarkers in cancer: Survey of diagnostic needs."
RESEARCH USE NOTIFICATION
Nanosphere, Inc. is required by the U.S. Food and Drug Administration (FDA) to certify in writing that its customers, who purchase or who are supplied with products labeled "For Research Use Only," acknowledge and understand that such products are not for use in diagnostic or therapeutic procedures. Tests performed with in vitro products intended for "Research Use Only" are tests used in a preclinical or nonclinical setting. While research tests may be performed using either clinical or nonclinical materials, research use devices have no intended clinical use and the testing performed is not designed to provide data addressing or demonstrating safety and effectiveness. We advise our customers to monitor the use of these products, to ensure that they are used for research purposes only. Please contact Nanosphere if you have questions.
The following link provides access to these abstracts: abstractsearch.asco.org/cgi-bin/ts.pl?index=442064&query=nanosphere&opt=exact
####
About Nanosphere
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(r) System, for direct genomic and ultra-sensitive protein detection. This easy to use and cost effective platform enables simple, low cost and highly sensitive genomic and protein testing on a single platform. Nanosphere is based in Northbrook, IL.
For more information, please click here
Contacts:
Winton Gibbons
(847) 400-9029
wgibbons@nanosphere.us
The Torrenzano Group
Rick Anderson
212-681-1700, Ext. 115
randerson@torrenzano.com
Copyright © Nanosphere
If you have a comment, please Contact us.
Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
http://www.nanotech-now.com/news.cgi?story_id=33397
Source: Nanosphere, Inc.
Nanosphere Co-founder and Board Member, Dr. Chad Mirkin, Awarded Prestigious Lemelson-MIT Prize for Revolutionary Advancements in Nanotechnology
NORTHBROOK, Ill., June 24, 2009 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today that its co-founder and member of its board of directors has been awarded the prestigious Lemelson-MIT Prize.
Chad Mirkin, Ph.D., a scientist and pioneer in the development of ultra-high sensitivity and selectivity assays based upon nanostructures, was cited as "a prolific inventor and entrepreneur, his innovations have the potential to transform the future of medical diagnostics and patient point-of-care and to ignite change across many industries from semi-conductors to healthcare," in the MIT announcement made earlier today.
The Lemelson-MIT Program recognizes outstanding inventors, encourages sustainable new solutions to real-world problems, and enables and inspires young people to pursue creative lives and careers through invention.
"MIT's recognition of both Dr. Mirkin's ground-breaking science and the promise of nanotechnology further validates the advances we make every day in improving healthcare and patient outcomes," said William P. Moffitt, president and chief executive officer of Nanosphere.
Nanosphere has commercialized many of the nanoparticle-based, medical diagnostic assays based upon the principles of Dr. Mirkin's inventions. This has led to the development of the Verigene ID(tm) System, Nanosphere's innovative biodiagnostic system that can test patients for several different disease targets at the same time, on-site in a research laboratory, community hospital, or doctor's office in less than an hour. "In the case of proteins, the test can be thousands of times more sensitive than any commercial protein detection system out there, and has the power to revolutionize medical diagnosis," explained Dr. Mirkin.
"Dr. Mirkin is an extraordinary scientist who is at the forefront of the growing field of nanotechnology," states Michael J. Cima, Faculty Director, Lemelson-MIT Program. "His inventions are paving the way for the emergence of nanotechnology in medicine, with impact that extends far beyond the scientific community. He is truly deserving of this honor."
Dr. Mirkin, the George B. Rathmann Professor of Chemistry and Director of the International Institute for Nanotechnology at Northwestern University, will accept the prize and present his accomplishments to the public at the Massachusetts Institute of Technology during the Lemelson-MIT Program's third-annual EurekaFest, a multi-day celebration of the inventive spirit, held June 25-27.
Dr. Mirkin is currently the director of the Northwestern University International Institute for Nanotechnology and the George B. Rathmann Professor of Chemistry, Professor of Medicine, and Professor of Materials Science and Engineering. Dr. Mirkin received his undergraduate training at Dickinson College (B.S., 1986) and his graduate training at the Pennsylvania State University, where he completed his Ph.D. in chemistry in 1989. That same year, he moved to MIT as a National Science Foundation Postdoctoral Fellow. Dr. Mirkin joined the faculty at Northwestern University in 1991.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(r) System for direct genomic and ultra-sensitive protein detection. This easy-to-use and cost-effective platform enables simple, low-cost and highly sensitive genomic and protein testing on a single platform. Nanosphere is based in Northbrook, IL. Additional information is available at www.nanosphere.us.
The Nanosphere, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4344
Safe Harbor Statement
Except for historical information, the matters discussed in this press release are "forward-looking statements" and are subject to risks and uncertainties. Actual results could differ materially from these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the following: (i) Nanosphere's ability to develop commercially viable products; (ii) Nanosphere's ability to achieve profitability; (iii) Nanosphere's ability to produce and market its products; (iv) Nanosphere's ability to obtain regulatory approval of its products; (v) Nanosphere's ability to protect its intellectual property; (vi) competition and alternative technologies; and (vii) Nanosphere's ability to obtain additional financing, if and when necessary, to support its operations. Additional risks are discussed in the Company's current filings with the Securities and Exchange Commission. Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. The forward-looking statements are made as of the date of this press release, and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
CONTACT: Nanosphere, Inc.
William P. Moffitt, President and CEO
847-400-9021
wmoffitt@nanosphere.us
The Torrenzano Group
Rick Anderson
212-681-1700, Ext. 115
randerson@torrenzano.com
http://www.globenewswire.com/newsroom/news.html?ref=rss&d=167829
Top 50 Smallest Small Cap Stocks
http://www.nasd100.com/2009/06/top-50-fastestgrowing-smallcap-stocks.html
Interesting list of companies...hmmm
#108 has a 25% growth projection!
GLTA
Investor 100
BBB-
First time poster and bookmarked your site!
Lots of winners and potential opportunities posted here!
Happy 4th to all!
Investor 100
Sepracor's depression candidate disappoints
Modified: Thursday, July 2, 2009, 1:16pm
Sheff this news could have helped DDSS spike up today?
Drug maker Sepracor Inc. said it is determining whether to continue the development of its most advanced candidate for the treatment of depression after a phase 2 clinical trial returned “inconclusive” results that fell short of the company’s initial goals.
Sepracor, based in Marlborough, Mass., said the 514-person study was designed to evaluate the safety and efficacy of its drug candidate, identified as SEP-225289, for the treatment of major depressive disorder. The company said the drug failed to result in a reduction in symptoms of depression following eight weeks of treatment.
In a regulatory filing late Wednesday, Sepracor (Nasdaq: SEPR) said it is “in the process of further analysis of the dose response and secondary endpoints to determine how or if it will move forward with SEP-225289."
http://boston.bizjournals.com/boston/stories/2009/06/29/daily53.html?ana=yfcpc
Motley Fool Article @ Bio-Meds
http://www.fool.com/investing/general/2009/06/30/5-stocks-bucking-the-downtrend.aspx
Positive note on BDSI!
GLTA
Investor 100
Labopharm amends debt facility agreement with Hercules
Yahoo 7:00am today
LAVAL, QC, June 25 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced it has amended its debt facility agreement with Hercules Technology Growth Capital, Inc. (NASDAQ: HTGC - News).
Based on regulatory approval and recent launch of its once-daily tramadol product in the United States, the Company has been able to establish more favourable repayment terms. Under the amended agreement, Labopharm has extended the date required to begin repaying the loan to July 1, 2010 from July 1, 2009, and the maturity date of the loan has been extended to June 1, 2012 from December 1, 2011. In consideration of the revised repayment terms, Labopharm will not draw down the remaining US$5 million of the US$25 million facility.
The amended agreement provides Labopharm with greater financial flexibility as the Company continues to transition to a commercial entity. The amendments will result in lower interest expense in 2009 and will provide additional liquidity through 2010 and 2011, strengthening the Company's balance sheet as commercial sales of its once-daily tramadol product increase following the recent U.S. launch. The remaining portion of the Warrant granted to HTGC under the terms of the original agreement vested at the completion of the amendment. All other terms of the agreement remain unchanged.
Labopharm also announced that it has entered into a $2.6 million credit facility with the National Bank of Canada (the "ABCP Facility"). This facility, which has a term of three years, is in furtherance of a previously announced agreement with the National Bank of Canada to borrow an amount of up to 45% of the principal value of the notes issued to the Company in the context of the restructuring of the Canadian asset-backed commercial paper, which amount the Company can, under certain conditions, repay at maturity by delivering the notes to the bank.
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, major European markets, and Australia, among others. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review by the FDA. The Company also has a robust 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. The Company disclaims any obligation to update these forward-looking statements.