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VIVUS Inc. Message Board

  • atlnsider atlnsider Oct 19, 2012 10:26 AM Flag

    Now Focus Shift to Scripts, Stendra & Amended REMS

    Vivus will likely file an appeal or re-examination request of the EMA CHMP's negative Qsiva opinion. However, in the near-term, Vivus, Vivus longs and the market in general will shift their primary focus to:

    (1) Increasing Qsymia scripts from week-to-week.

    (2) Stendra partnership or buyout soon.

    (3) Stendra approval by the EMA CHMP in Europe

    (4) The FDA approval of the amended Qsymia REMS to allow Qsymia patients to be able to get their Qsymia scripts filled at their local neighborhood retail pharmaicies, such as: Walgreens, CVS, and Walmart.

    Sentiment: Strong Buy

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    • I like how your focused on stendra all of a sudden, your still expecting a buyout by end of the year ATL lol. Stendra accounts for 500M marketcap, and after ema, FDA can revise REMS for vvus. Your script numbers going up only make belviq look better. vvus has been knocking off drugs since VVUS MUSE ed drug lol, google it. Stendra ain't going anywhere

    • Must fight propaganda. Must...stay...focused...on stock dropping...on...MONDAY!

    • I agree atlnsider,

      the market will shift their primary focus to:

      (1) Increasing Qsymia scripts from week-to-week, ***and whether or not they are increasing at an increasing rate, or increasing at a decreasing rate.***

      (2) **IF** they get Stendra partnership or buyout soon....no guarantee

      (3) **IF** they get Stendra approval by the EMA CHMP in Europe....no guarantee

      (4) **IF** the FDA approval of the amended Qsymia ....no guarantee. Even with approval, it's just a small victory at best.

      and all of this against the backdrop of "EU DENIAL"

      i hope you are OK with me adding the **IF** for 2, 3 and 4....because that's what they are

    • I agree atlnsider,

      the market will shift their primary focus to:

      (1) Increasing Qsymia scripts from week-to-week, ***and whether or not they are increasing at an increasing rate, or increasing at a decreasing rate.***

      (2) **IF** they get Stendra partnership or buyout soon....no guarantee

      (3) **IF** they get Stendra approval by the EMA CHMP in Europe....no guarantee

      (4) **IF** the FDA approval of the amended Qsymia ....no guarantee. Even with approval, it's just a small victory at best.

      and all of this against the backdrop of "EU DENIAL"

      i hope you are OK with me adding the **IF** for 2, 3 and 4....because that's what they are

    • They better update shareholders on STENDRA launch plans at the earnings conference!!!!!!!!!! It's almost criminal to let STENDRA sit idle for 6 months after FDA approval. Surely they owe shareholders an explanation. Do they need a class action suit to force them to launch STENDRA in US?

    • I finally agree with an atlincider statement - the script numbers are what will tell the VVUS story. And so far the numbers are anemic.

    • Remember VVUS will still need a partner for other world market areas. Plus they need to ink a deal for Stendra very soon.

      Sentiment: Strong Buy

    • Important Safety Information

      Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.

      Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

      Qsymia can cause an increase in resting heart rate. Regular measurement of resting heart rate is recommended for all patients taking Qsymia, especially patients with cardiac or cerebrovascular disease or when initiating or increasing the dose of Qsymia. Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is
      not recommended.

      Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Qsymia in patients who experience suicidal thoughts or behaviors. Qsymia is not recommended in patients with a history of suicidal attempts or active suicidal ideation.

      Acute angle closure glaucoma has been reported in patients treated with topiramate, a component of Qsymia. Symptoms include acute onset of decreased visual acuity and/or eye pain. Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. The primary treatment to reverse symptoms is immediate discontinuation of Qsymia.

      Qsymia can cause mood disorders, including depression and anxiety, as well as insomnia. Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties). Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles.

      Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients treated with Qsymia. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Qsymia.

      Qsymia can cause an increase in serum creatinine. If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia.

      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). Qsymia has not been studied in combination with insulin. A reduction in the dose of antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.

      The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

      To report negative side effects, contact VIVUS, Inc. at 1-888-998-4887 or FDA at 1-800-FDA-1088

      Please read the Full Prescribing Information for Qsymia.

    • I am still focused on that $80 or $90 or was it $120 share price.

      Any time now, I suppose.

 
VVUS
2.31-0.01(-0.43%)Jul 2 4:00 PMEDT