Seeking Alpha
View as an RSS Feed

Spencer Osborne  

View Spencer Osborne's Comments BY TICKER:
Latest  |  Highest rated
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    Gary,

    You have every right to make that decision for yourself. Here are the adverse things for belviq

    5 WARNINGS AND PRECAUTIONS

    5.1 Serotonin Syndrome or Neuroleptic Malignant Syndrome
    (NMS)-like Reactions

    BELVIQ is a serotonergic drug. The development of a potentially life threatening serotonin syndrome or Neuroleptic Malignant Syndrome
    (NMS)-like reactions have been reported during use of serotonergic
    drugs, including, but not limited to, selective serotonin-norepinephrine
    reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors
    (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary
    supplements such as St. John’s Wort and tryptophan, drugs that impair
    metabolism of serotonin (including monoamine oxidase inhibitors
    [MAOIs]), dextromethorphan, lithium, tramadol, antipsychotics or other
    dopamine antagonists, particularly when used in combination [see Drug
    Interactions (7.1)].
    Serotonin syndrome symptoms may include mental status changes (e.g.,
    agitation, hallucinations, coma), autonomic instability (e.g., tachycardia,
    labile blood pressure, hyperthermia), neuromuscular aberrations (e.g.,
    hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g.,
    nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe
    form, can resemble neuroleptic malignant syndrome, which includes
    hyperthermia, muscle rigidity, autonomic instability with possible rapid
    fluctuation of vital signs, and mental status changes. Patients should be
    monitored for the emergence of serotonin syndrome or NMS-like signs and
    symptoms.
    The safety of BELVIQ when coadministered with other serotonergic or
    antidopaminergic agents, including antipsychotics, or drugs that impair
    metabolism of serotonin, including MAOIs, has not been systematically
    evaluated and has not been established.
    If concomitant administration of BELVIQ with an agent that affects the
    serotonergic neurotransmitter system is clinically warranted, extreme
    caution and careful observation of the patient is advised, particularly
    during treatment initiation and dose increases. Treatment with BELVIQ
    and any concomitant serotonergic or antidopaminergic agents, including
    antipsychotics, should be discontinued immediately if the above events
    occur and supportive symptomatic treatment should be initiated [see
    Adverse Reactions (6.1) and Drug Interactions (7.1)].

    5.2 Valvular Heart Disease
    Regurgitant cardiac valvular disease, primarily affecting the mitral and/
    or aortic valves, has been reported in patients who took serotonergic
    drugs with 5-HT2B receptor agonist activity. The etiology of the regurgitant
    valvular disease is thought to be activation of 5-HT2B receptors on cardiac
    interstitial cells. At therapeutic concentrations, BELVIQ is selective for
    5-HT2C receptors as compared to 5-HT2B receptors. In clinical trials of
    1-year duration, 2.4% of patients receiving BELVIQ and 2.0% of patients
    receiving placebo developed echocardiographic criteria for valvular
    regurgitation at one year (mild or greater aortic regurgitation and/or
    moderate or greater mitral regurgitation): none of these patients was
    symptomatic [see Adverse Reactions (6.1) see Clinical Pharmacology
    (12.1)].
    BELVIQ has not been studied in patients with congestive heart failure
    or hemodynamically-signif... valvular heart disease. Preliminary data
    suggest that 5HT2B receptors may be overexpressed in congestive heart
    failure.Therefore, BELVIQ should be used with caution in patients with
    congestive heart failure.
    BELVIQ should not be used in combination with serotonergic and
    dopaminergic drugs that are potent 5-HT2B receptor agonists and are
    known to increase the risk for cardiac valvulopathy (e.g., cabergoline).
    Patients who develop signs or symptoms of valvular heart disease,
    including dyspnea, dependent edema, congestive heart failure, or a new
    cardiac murmur while being treated with BELVIQ should be evaluated and
    discontinuation of BELVIQ should be considered.

    5.3 Cognitive Impairment
    In clinical trials of at least one year in duration, impairments in attention
    and memory were reported adverse reactions associated with 1.9% of
    patients treated with BELVIQ and 0.5% of patients treated with placebo,
    and led to discontinuation in 0.3% and 0.1% of these patients, respectively.
    Other reported adverse reactions associated with BELVIQ in clinical trials
    included confusion, somnolence, and fatigue [see Adverse Reactions
    (6.1)].
    Since BELVIQ has the potential to impair cognitive function, patients
    should be cautioned about operating hazardous machinery, including
    automobiles, until they are reasonably certain that BELVIQ therapy does
    not affect them adversely [see Patient Counseling Information (17)].
    5.4 Psychiatric Disorders
    Events of euphoria, hallucination, and dissociation were seen with BELVIQ
    at supratherapeutic doses in short-term studies [see Adverse Reactions
    (6.1), Drug Abuse and Dependence (9.2), and Overdosage (10)]. In
    clinical trials of at least 1-year in duration, 6 patients (0.2%) treated with
    BELVIQ developed euphoria, as compared with 1 patient (<0.1%) treated
    with placebo. Doses of BELVIQ should not exceed 10 mg twice a day.
    Some drugs that target the central nervous system have been associated
    with depression or suicidal ideation. Patients treated with BELVIQ should
    be monitored for the emergence or worsening of depression, suicidal
    thoughts or behavior, and/or any unusual changes in mood or behavior.
    Discontinue BELVIQ in patients who experience suicidal thoughts or
    behaviors [see Adverse Reactions (6.1)].
    5.5 Potential Risk of Hypoglycemia in Patients with Type 2 Diabetes
    Mellitus on Anti-diabetic Therapy
    Weight loss may increase the risk of hypoglycemia in patients with type 2
    diabetes mellitus treated with insulin and/or insulin secretagogues (e.g.,
    sulfonylureas); hypoglycemia was observed in clinical trials with BELVIQ.
    BELVIQ has not been studied in combination with insulin. Measurement
    of blood glucose levels prior to starting BELVIQ and during BELVIQ
    treatment is recommended in patients with type 2 diabetes. Decreases
    in medication doses for anti-diabetic medications which are non-glucose
    dependent should be considered to mitigate the risk of hypoglycemia.
    If a patient develops hypoglycemia after starting BELVIQ, appropriate
    changes should be made to the anti-diabetic drug regimen [see Adverse
    Reactions (6.1)].
    5.6 Priapism
    Priapism (painful erections greater than 6 hours in duration) is a potential
    effect of 5-HT2C receptor agonism.
    If not treated promptly, priapism can result in irreversible damage to the
    erectile tissue. Men who have an erection lasting greater than 4 hours,
    whether painful or not, should immediately discontinue the drug and seek
    emergency medical attention.
    BELVIQ should be used with caution in men who have conditions that might
    predispose them to priapism (e.g., sickle cell anemia, multiple myeloma,
    or leukemia), or in men with anatomical deformation of the penis (e.g.,
    angulation, cavernosal fibrosis, or Peyronie’s disease). There is limited
    experience with the combination of BELVIQ and medication indicated for
    erectile dysfunction (e.g., phosphodiesterase type 5 inhibitors). Therefore,
    the combination of BELVIQ and these medications should be used with
    caution.
    5.7 Heart Rate Decreases
    In clinical trials of at least 1-year in duration, the mean change
    in heart rate (HR) was -1.2 beats per minute (bpm) in BELVIQ
    and -0.4 bpm in placebo-treated patients without diabetes and
    -2.0 beats per minute (bpm) in BELVIQ and -0.4 bpm in placebotreated
    patients with type 2 diabetes. The incidence of HR less than
    50 bpm was 5.3% in BELVIQ and 3.2% in placebo-treated patients without
    diabetes and 3.6% in BELVIQ and 2.0% in placebo-treated patients
    with type 2 diabetes. In the combined population, adverse reactions of
    bradycardia occurred in 0.3% of BELVIQ and 0.1% of placebo-treated
    patients. Use with caution in patients with bradycardia or a history of heart
    block greater than first degree.
    5.8 Hematological Changes
    In clinical trials of at least one year in duration, adverse reactions of
    decreases in white blood cell count (including leukopenia, lymphopenia,
    neutropenia, and decreased white cell count) were reported in 0.4% of
    patients treated with BELVIQ as compared to 0.2% of patients treated with
    placebo. Adverse reactions of decreases in red blood cell count (including
    anemia and decreases in hemoglobin and hematocrit) were reported by
    1.3% of patients treated with BELVIQ as compared to 1.2% treated with
    placebo [see Adverse Reactions (6.1)]. Consider periodic monitoring of
    complete blood count during treatment with BELVIQ.
    5.9 Prolactin Elevation
    Lorcaserin moderately elevates prolactin levels. In a subset of placebocontrolled
    clinical trials of at least one year in duration, elevations of
    prolactin greater than the upper limit of normal, two times the upper limit
    of normal, and five times the upper limit of normal, measured both before
    and 2 hours after dosing, occurred in 6.7%, 1.7%, and 0.1% of BELVIQtreated
    patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients,
    respectively [see Adverse Reactions (6.1)]. Prolactin should be measured
    when symptoms and signs of prolactin excess are suspected (e.g.,
    galactorrhea, gynecomastia). There was one patient treated with BELVIQ
    who developed a prolactinoma during the trial. The relationship of BELVIQ
    to the prolactinoma in this patient is unknown.
    5.10 Pulmonary Hypertension
    Certain centrally-acting weight loss agents that act on the serotonin
    system have been associated with pulmonary hypertension, a rare but
    lethal disease. Because of the low incidence of this disease, the clinical
    trial experience with BELVIQ is inadequate to determine if BELVIQ
    increases the risk for pulmonary hypertension.
    6 ADVERSE REACTIONS
    The following important adverse reactions are described below and elsewhere
    in labeling:
    • Serotonin Syndrome or NMS-like Reactions [see Warnings
    and Precautions (5.1)]
    • Valvular Heart Disease [see Warnings and Precautions (5.2)]
    • Cognitive Impairment [see Warnings and Precautions (5.3)]
    • Psychiatric Disorders [see Warnings and Precautions (5.4)]
    • Hypoglycemia [see Warnings and Precautions (5.5)]
    • Heart Rate Decreases [see Warnings and Precautions (5.7)]
    • Hematological Changes [see Warnings and Precautions (5.8)]
    • Prolactin Elevation [see Warnings and Precautions (5.9)]
    6.1 Clinical Trials Experience
    In the BELVIQ placebo-controlled clinical database of trials of at least one
    year in duration, of 6888 patients (3451 BELVIQ vs. 3437 placebo; age
    range 18-66 years, 79.3% women, 66.6% Caucasians, 19.2% Blacks,
    11.8% Hispanics, 2.4% other, 7.4% type 2 diabetics), a total of 1969
    patients were exposed to BELVIQ 10 mg twice daily for 1 year and 426
    patients were exposed for 2 years.
    In clinical trials of at least one year in duration, 8.6% of patients treated
    with BELVIQ prematurely discontinued treatment due to adverse
    reactions, compared with 6.7% of placebo-treated patients. The most
    common adverse reactions leading to discontinuation more often among
    BELVIQ treated patients than placebo were headache (1.3% vs. 0.8%),
    depression (0.9% vs. 0.5%) and dizziness (0.7% vs. 0.2%).
    Most Common Adverse Reactions
    Because clinical trials are conducted under widely varying conditions,
    adverse reaction rates observed in the clinical trials of a drug cannot be
    directly compared to rates in the clinical trials of another drug and may not
    reflect the rates observed in practice.
    The most common adverse reactions for non-diabetic patients (greater
    than 5% and more commonly than placebo) treated with BELVIQ
    compared to placebo were headache, dizziness, fatigue, nausea, dry
    mouth, and constipation. The most common adverse reactions for diabetic
    patients were hypoglycemia, headache, back pain, cough, and fatigue.
    Adverse reactions that were reported by greater than or equal to 2% of
    patients and were more frequently reported by patients taking BELVIQ
    compared to placebo are summarized in Table 2 (non-diabetic subjects)
    and Table 3 (subjects with type 2 diabetes mellitus).
    Table 2. Adverse Reactions Reported by Greater Than or Equal to
    2% of BELVIQ Patients and More Commonly than with
    Placebo in Patients without Diabetes Mellitus
    Number of
    Patients (%)
    Adverse Reaction
    BELVIQ
    10 mg BID
    N=3195
    Placebo
    N=3185
    Gastrointestinal Disorders
    Nausea 264 (8.3) 170 (5.3)
    Diarrhea 207 (6.5) 179 (5.6)
    Constipation 186 (5.8) 125 (3.9)
    Dry Mouth 169 (5.3) 74 (2.3)
    Vomiting 122 (3.8) 83 (2.6)
    General Disorders And Administration
    Site Conditions
    Fatigue 229 (7.2) 114 (3.6)
    Infections And Infestations
    Upper respiratory tract infection 439 (13.7) 391 (12.3)
    Nasopharyngitis 414 (13.0) 381 (12.0)
    Urinary tract infection 207 (6.5) 171 (5.4)
    Musculoskeletal And Connective Tissue Disorders
    Back pain 201 (6.3) 178 (5.6)
    Musculoskeletal pain 65 (2.0) 43 (1.4)
    Nervous System Disorders
    Headache 537 (16.8) 321 (10.1)
    Dizziness 270 (8.5) 122 (3.8)
    Respiratory, Thoracic And Mediastinal Disorders
    Cough 136 (4.3) 109 (3.4)
    Oropharyngeal pain 111 (3.5) 80 (2.5)
    Sinus congestion 93 (2.9) 78 (2.4)
    Skin And Subcutaneous Tissue Disorders
    Rash 67 (2.1) 58 (1.8)
    Table 3. Adverse Reactions Reported by Greater Than or Equal
    to 2% of BELVIQ Patients and More Commonly than with
    Placebo in Patients with Type 2 Diabetes Mellitus
    Number of
    Patients (%)
    Adverse Reaction
    BELVIQ
    10mg BID
    N=256
    Placebo
    N=252
    Gastrointestinal Disorders
    Nausea 24 (9.4) 20 (7.9)
    Toothache 7 (2.7) 0
    General Disorders And
    Administration Site Conditions
    Fatigue 19 (7.4) 10 (4.0)
    Peripheral edema 12 (4.7) 6 (2.4)
    Immune System Disorders
    Seasonal allergy 8 (3.1) 2 (0.8)
    Infections And Infestations
    Nasopharyngitis 29 (11.3) 25 (9.9)
    Urinary tract infection 23 (9.0) 15 (6.0)
    Gastroenteritis 8 (3.1) 5 (2.0)
    Metabolism And Nutrition Disorders
    Hypoglycemia 75 (29.3) 53 (21.0)
    Worsening of diabetes mellitus 7 (2.7) 2 (0.8)
    Decreased appetite 6 (2.3) 1 (0.4)
    Musculoskeletal And Connective Tissue Disorders
    Back pain 30 (11.7) 20 (7.9)
    Muscle spasms 12 (4.7) 9 (3.6)
    Nervous System Disorders
    Headache 37 (14.5) 18 (7.1)
    Dizziness 18 (7.0) 16 (6.3)
    Psychiatric Disorders
    Anxiety 9 (3.5) 8 (3.2)
    Insomnia 9 (3.5) 6 (2.4)
    Stress 7 (2.7) 3 (1.2)
    Depression 6 (2.3) 5 (2.0)
    Respiratory, Thoracic And Mediastinal Disorders
    Cough 21 (8.2) 11 (4.4)
    Vascular Disorders
    Hypertension 13 (5.1) 8 (3.2)
    Other Adverse Reactions
    Serotonin-associated Adverse Reactions
    SSRIs, SNRIs, bupropion, tricyclic antidepressants, and MAOIs were
    excluded from the BELVIQ trials. Triptans and dextromethorphan were
    permitted: 2% and 15%, respectively, of patients without diabetes and
    1% and 12%, respectively, of patients with type 2 diabetes experienced
    concomitant use at some point during the trials. Two patients treated with
    BELVIQ in the clinical program experienced a constellation of symptoms
    and signs consistent with serotonergic excess, including one patient
    on concomitant dextromethorphan who reported an event of serotonin
    syndrome. Some symptoms of possible serotonergic etiology that are
    included in the criteria for serotonin syndrome were reported by patients
    treated with BELVIQ and placebo during clinical trials of at least 1 year
    in duration. In both groups, chills were the most frequent of these events
    (1.0% vs. 0.2%, respectively), followed by tremor (0.3% vs. 0.2%),
    confusional state (0.2% vs. less than 0.1%), disorientation (0.1% vs.
    0.1%) and hyperhidrosis (0.1% vs. 0.2%). Because serotonin syndrome
    has a very low incidence, an association between BELVIQ and serotonin
    syndrome cannot be excluded on the basis of clinical trial results [see
    Warnings and Precautions (5.1)].
    Hypoglycemia in Patients with Type 2 Diabetes
    In a clinical trial of patients with type 2 diabetes mellitus, hypoglycemia
    requiring the assistance of another person occurred in 4 (1.6%) of
    BELVIQ-treated patients and in 1 (0.4%) placebo-treated patient. Of these
    4 BELVIQ-treated patients, all were concomitantly using a sulfonylurea
    (with or without metformin). BELVIQ has not been studied in patients
    taking insulin. Hypoglycemia defined as blood sugar less than or equal
    to 65 mg/dL and with symptoms occurred in 19 (7.4%) BELVIQ-treated
    patients and 16 (6.3%) placebo-treated patients.
    Cognitive Impairment
    In clinical trials of at least 1-year duration, adverse reactions related to
    cognitive impairment (e.g., difficulty with concentration/attention, difficulty
    with memory, and confusion) occurred in 2.3% of patients taking BELVIQ
    and 0.7% of patients taking placebo.
    Psychiatric Disorders
    Psychiatric disorders leading to hospitalization or drug withdrawal
    occurred more frequently in patients treated with BELVIQ (2.2%) as
    compared to placebo (1.1%) in non-diabetic patients.
    Euphoria. In short-term studies with healthy individuals, the incidence of
    euphoric mood following supratherapeutic doses of BELVIQ (40 and 60 mg)
    was increased as compared to placebo [see Drug Abuse and Dependence
    (9.2)]. In clinical trials of at least 1-year duration in obese patients, euphoria
    was observed in 0.17% of patients taking BELVIQ and 0.03% taking
    placebo.
    Depression and Suicidality. In trials of at least one year in duration, reports
    of depression/mood problems occurred in 2.6% BELVIQ-treated vs. 2.4%
    placebo-treated and suicidal ideation occurred in 0.6% BELVIQ-treated
    vs. 0.4% placebo-treated patients. 1.3% of BELVIQ patients vs. 0.6% of
    placebo patients discontinued drug due to depression-, mood-, or suicidal
    ideation-related events.
    Laboratory Abnormalities
    Lymphocyte and Neutrophil Counts. In clinical trials of at least 1-year
    duration, lymphocyte counts were below the lower limit of normal in 12.2%
    of patients taking BELVIQ and 9.0% taking placebo, and neutrophil counts
    were low in 5.6% and 4.3%, respectively.
    Hemoglobin. In clinical trials of at least 1-year duration, 10.4% of patients
    taking BELVIQ and 9.3% taking placebo had hemoglobin below the lower
    limit of normal at some point during the trials.
    Prolactin. In clinical trials, elevations of prolactin greater than the upper
    limit of normal, two times the upper limit of normal, and five times the
    upper limit of normal, occurred in 6.7%, 1.7%, and 0.1% of BELVIQtreated
    patients and 4.8%, 0.8%, and 0.0% of placebo-treated patients,
    respectively.
    Eye disorders
    More patients on BELVIQ reported an eye disorder than patients on
    placebo in clinical trials of patients without diabetes (4.5% vs. 3.0%) and
    with type 2 diabetes (6.3% vs. 1.6%). In the population without diabetes,
    events of blurred vision, dry eye, and visual impairment occurred in
    BELVIQ-treated patients at an incidence greater than that of placebo.
    In the population with type 2 diabetes, visual disorders, conjunctival
    infections, irritations, and inflammations, ocular sensation disorders, and
    cataract conditions occurred in BELVIQ-treated patients at an incidence
    greater than placebo.
    Echocardiographic Safety Assessments
    The possible occurrence of regurgitant cardiac valve disease was
    prospectively evaluated in 7794 patients in three clinical trials of at least
    one year in duration, 3451 of whom took BELVIQ 10 mg twice daily.
    The primary echocardiographic safety parameter was the proportion
    of patients who developed echocardiographic criteria of mild or greater
    aortic insufficiency and/or moderate or greater mitral insufficiency from
    baseline to 1 year. At 1 year, 2.4% of patients who received BELVIQ and
    2.0% of patients who received placebo developed valvular regurgitation.
    The relative risk for valvulopathy with BELVIQ is summarized in Table
    4. BELVIQ was not studied in patients with congestive heart failure or
    hemodynamically-signif... valvular heart disease [see Warnings and
    Precautions (5.2)].
    Table 4. Incidence of FDA-Defined Valvulopathy at Week 52
    by Treatment Group1
    Study 1 Study 2 Study 3
    BELVIQ
    N=1278
    Placebo
    N=1191
    BELVIQ
    N=1208
    Placebo
    N=1153
    BELVIQ
    N=210
    Placebo
    N=209
    FDA-defined
    Valvulopathy,
    n (%)
    34
    (2.7)
    28
    (2.4)
    24
    (2.0)
    23
    (2.0)
    6
    (2.9)
    1
    (0.5)
    Relative
    Risk (95% CI)
    1.13
    (0.69, 1.85)
    1.00
    (0.57, 1.75)
    5.97
    (0.73, 49.17)
    Pooled
    RR (95% CI) 1.16 (0.81, 1.67)
    1Patients without valvulopathy at baseline who received study medication and had a post-baseline
    echocardiogram; ITT-intention-to-treat; LOCF-last observation carried forward.
    7 DRUG INTERACTIONS
    7.1 Use with Other Agents that Affect Serotonin Pathways
    Based on the mechanism of action of BELVIQ and the theoretical potential
    for serotonin syndrome, use with extreme caution in combination with
    other drugs that may affect the serotonergic neurotransmitter systems,
    including, but not limited to, triptans, monoamine oxidase inhibitors
    (MAOIs, including linezolid, an antibiotic which is a reversible nonselective
    MAOI), selective serotonin reuptake inhibitors (SSRIs), selective
    serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan,
    tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan,
    and St. John’s Wort [see Warnings and Precautions (5.1)].
    7.2 Cytochrome P450 (2D6) substrates
    Use caution when administering BELVIQ together with drugs that are
    CYP 2D6 substrates, as BELVIQ can

    That is quite a list. This drug, or any drug, should not be taken like candy
    Mar 28, 2015. 08:02 PM | 1 Like Like |Link to Comment
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    Gary....

    The proper drug for a person is the one that works effectively. The risks of ALL of these drugs (Belviq included) are not worth it. Proper diet and proper exercise are the BEST solution. For the 1 in 100 that PROPER diet and PROPER exercise do not work for, I would want them to see a doctor and assess what works best and does for them as an individual. I really do not care if that solution in Belviq, Contrave, Qsymia, Belarinib, Saxenda, or phentermine.

    I find it insanely humorous that investors in Arena take the stance they do. I also find it fascinating.

    So, let me pose a question to you....

    Would you rather take a drug that gives you adverse reactions or simply skip the drug, work out and eat the way you should. Belviq is far from being free of adverse reactions. The others are as well.

    Mar 28, 2015. 07:22 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    Counter....

    An investment is an investment. I do not like seafood either, but that does not mean that I may not invest in a company that is involved in seafood. I do not like GM very much, but that will not stop me from investing in the company if I think there is an opportunity.
    Mar 28, 2015. 06:46 PM | 1 Like Like |Link to Comment
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    Gary,

    If you were going to navigate in a cave, is it safer to navigate in a cave that has been mapped out, or one that has never been explored? There is a "safety" in knowing the dangers. There is a "risk" in the unknown. the ingredients of Contrave are well known and well understood.

    Mar 28, 2015. 06:44 PM | 1 Like Like |Link to Comment
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    Gary...

    The near term has to happen before the longer term can play out. How the long term is financed is a big question.

    There is nothing arena can really do with Belviq. That drug us under Eisai control.n Eisai needs to get to a point where it makes money. Eisai seems to slready be placing Belviq lower on its totem pole. We simply need to see Eisai step up to the plate

    Why is Contrave scary? It's ongredients are well known, well understood, and have a well documented history.
    Mar 28, 2015. 03:24 PM | 2 Likes Like |Link to Comment
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    tail....

    They were already rejected in swizerland
    Mar 28, 2015. 02:18 PM | 2 Likes Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    counter.....

    I think you have missed your meds today.

    All drugs have many side effects. If you were able to comprehend what i have written, I state quite clearly I am not a fan of any of them. I do not personally like script drugs as a general rule.

    Feel free to go over side effects of all of them in your free time. Everyone else already knows the side effects of these drugs.

    Do you have anything real to discuss, or are you simply trying to conduct your mental masturbation in front of all of us?
    Mar 28, 2015. 01:27 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    counter....

    Why do you try to interpret things that are light years above your thought process?

    In no way am I saying that nothing else will be approved. 999 people out of 1,000 would understand this....even the real mentally challenged. you are the one person that fell short of understanding. In fact, I would say that 999,999,999 out of 1,000,000,000 would not have arrived at the conclusion you have.

    Sometime we say that people like you are unique. That is a kind way of saying that you have severe disabilities in reading, math, and social situations. 40 years ago you would have been placed in an institution.
    Mar 28, 2015. 01:22 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    counter.....

    "give it up Spencer...you are making yourself look worse. and I thought that could be done."

    I think you meant to say, "I thought that could not be done"

    No worries....lesser intellects such as yourself get these things confused often. I am used to suspect that your were dropped on your head a few times. That may be the case, but I think perhaps your family tree is more vertical than it should be.
    Mar 28, 2015. 01:18 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    counter....

    "I'm sure you are right and all of these other people are wrong."

    Wow! You got something right. Congratulations! Here is a gold star for the day. perhaps you will be lucky and earn a few more
    Mar 28, 2015. 01:16 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    Counter....

    I would suggest that you do a little reading before asking questions. If you want me to spoon feed you information that I have already covered you will need to give me your social security number so that i can claim you as a dependent on my taxes.

    You can refer to the following:

    http://seekingalpha.co...

    http://seekingalpha.co...

    http://seekingalpha.co...

    Get back to me in several hours after you have had a chance to read. You may want to read each several times to increase the odds of comprehension. If some of the words are to big, ask a neighbor to help.
    Mar 28, 2015. 01:14 PM | 1 Like Like |Link to Comment
  • Has Orexigen Delivered A Death Knell To Vivus? [View article]
    counter....

    more free rent in your head. Thank You.

    No stock is beloved to me.

    Thank you for showing up. I feel that I have now satisfied your need for attention. I like to do a little good for those with lower intellects. It makes me feel good to know that I was a bright spot in your otherwise dreary existence.
    Mar 28, 2015. 12:59 PM | 1 Like Like |Link to Comment
  • Orexigen Gains Market Share With Contrave Again [View article]
    wm...

    patent is fine IMO. Having Takeda as a partner reinforces the patent strength
    Mar 28, 2015. 12:40 PM | 2 Likes Like |Link to Comment
  • Arena: Belviq Sales Flatter Than Needed - Q1 Revenue Miss Likely [View article]
    Jim....

    The peak of weight loss season is the middle of november??????????????...

    Have you ever looked at historical obesity sales charts? The first downshift in pace starts in july and the second downshift to pace happens in Septenber. The peak is the beginning of October, but peak pace is in June

    While 80 million people overweight seems compelling, it is not. Qsymia has been on the market for nearly three years and belviq nearly two years. phentermine has been here for a very long time.

    Q sales have been flat for 18 months. B sales have been much slower than needed. P sales have been consistent for quite some time. The growth in sales that Q, B, and C have had is in expanding the market and not in taking away from phentermine.

    Samples.....

    Oh my.....The largest excuse of the moment. Samples are not having a big impact. A kid could read the financials and know that the samples program is not very big. It is 6 months old now.... SIX MONTHS! If samples were working, it would be showing through. The One MD you are relying on is the same MD that last fall said that Belviq would overtake phentermine in a few weeks. He is the same MD that said sales this year would be 3.5 million. Take what he says about samples and divide it by a factor of 10 to 15. better yet, read the financials. Look at what was spent on samples, look at the inventory levels at eisai, look at the inventory levels at Arena. Again, a grade school kid can arrive at the samples with addition and subtraction.

    Jim, stop the "samples" excuse train. The fact of the matter is that the revenue is going to be shy of what is needed. Samples are not converting to sales in a meaningful manner. Free samples are between 25k and 45k per quarter. The goal of samples is to convert at least 5%. less than that and it is not doing its job.

    Reserve judgment on marketing effort?????? Jim, We are approaching TWO YEARS since launch!
    Mar 28, 2015. 11:11 AM | 4 Likes Like |Link to Comment
  • Orexigen Gains Market Share With Contrave Again [View article]
    Prx.....

    I do not think any are exiting the market in the next year. Qsymia is the one in the most trouble with flat sales and actavis and Teva filing to make a generic. The biggest worry I have in the sector is a generic Qsymia marketed bt actavis at a very low price point. Lawsuit with actavis is a couple years out. I wrote about it a while back.

    Saenda is interesting. I want to see launch strategy and price point. If saenda (which is double strength victoza) gets good insurance coverage, it could be an interesting play. Saenda will actually boost victoza sales in my opinion. Docs will know it is same drug.
    Mar 28, 2015. 10:39 AM | 2 Likes Like |Link to Comment
COMMENTS STATS
8,204 Comments
6,656 Likes