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VIVUS Inc. Message Board

  • slowerclimate slowerclimate Sep 24, 2012 10:33 AM Flag

    I think it's important to know why the EU may not approve

    Qsymia. We really don't have enough information. With Belviq, we know that they do not reach the standard of efficacy that the EU requires, but Qsymia does. So where, exactly is the problem?

    Sentiment: Strong Buy

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    • I agree Slowerclimate.

      The EMA report that should be released by October 19th should explain in more detail, the reasons for any negative decision. Vivus can then decide if they want to appeal this decision.

      According to the EMA's own documents, the reason that the marketing authority for Phentermlne was originally withdrawn in Europe was "due to a lack of therapeutic efficacy", not due to safety concerns.

      The lack of therapeutic efficacy was more because the average weight loss for Phentermlne by itself was only about 6.2% (by the way, this is more than Belviq's average of 5.8%), and the EMA requires that the average weight loss is more than 10% of total weight, and at least 5% more than placebo (by the way, Belviq was only 3.3% higher than placebo).

      In addition, Phentermlne was only approved for the short-term treatment of obesity (no more than 3 months). Most patients who took Phentermlne for 3 months would regain most, if not all of the weight that they had lost. Obesity is a chronic, long-term condition that needs a long-term treatment like Qsymia (Qsiva).

      Sentiment: Strong Buy

    • Per credit suisse report Eu concern is the cv. Vvus think they will have this study done by 2014 and so the lunch will be in 2015. They also reduced vvus valuation to $29 from $34.

    • The simple answer is: "Phen is banned in Europe."

      What are the European efficacy guidelines?

 
VVUS
4.16-0.20(-4.59%)Sep 19 4:00 PMEDT

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