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Vivus (VVUS +2.1%) shares gyrate wildly after an FDA advisory panel votes to require...

Vivus (VVUS +2.1%) shares gyrate wildly after an FDA advisory panel votes to require cardiovascular outcomes trials for drugs without a theoretical risk or signal for cardiovascular harm. The vote could be seen as a negative for weight-loss drug companies such as VVUS, OREX -2% and ARNA +5.3%, who now may have to run additional tests to convince the FDA of a drug's safety.
Comments (5)
  • Alfie1
    , contributor
    Comments (36) | Send Message
     
    "...for drugs without a theoretical risk or signal for cardiovascular harm.."

     

    This makes no sense. If there was not a theoretical risk, why would trials be needed at all? Was this statement incorrectly written?
    29 Mar 2012, 04:26 PM Reply Like
  • eviljoe35
    , contributor
    Comments (92) | Send Message
     
    no pre trial is required for VVUS, it is very unlikely according to a FDA Spokesperson.
    29 Mar 2012, 09:29 PM Reply Like
  • wagnem
    , contributor
    Comments (12) | Send Message
     
    The third question, on which there was a vote yesterday was whether testing should be undertaken on obesity drug candidates that did not show any indication of CV risk. The panel voted 17 - 6 (it was a late 2am for me in Kaz but this is the final count that I remember). As I understand, this vote had nothing to do with VVUS because VVUS had a CV indication, a slightly elevated heart rate, but it also lowered blood pressure (a deemed benefit). They discussed this at the panel earlier in the day, but if journalists weren't listening for the full two days, they could easily have missed that.

     

    I fully expect approval on 17 April, with agreed post-approval CV testing of QNEXA to cover CV as an anti-obesity medication as well as for diabetes treatment.

     

    The question 3 vote appears to be a knee jerk reaction (to previous CV problems related to historically used anti-obesity drugs) and calls for testing on all future anti-obesity candidates even if no CV risk was established in Phase I or Phase II testing.

     

    Once again, I do not believe that this panel vote will adversely affect QNEXA getting FDA approval on 17 April.

     

    Just for the record, I am long VVUS.
    30 Mar 2012, 12:28 AM Reply Like
  • MexCom
    , contributor
    Comments (3050) | Send Message
     
    Another rumor on the boards is that this vote would have no effect on drugs already in the pipeline. Post approval trial is the most likely outcome.

     

    Keep in mind that approval coincides with the "new bathing suit" purchasing season. Initial scripts written for QNEXA will be greater than initial expectations.
    30 Mar 2012, 06:26 AM Reply Like
  • phemale60
    , contributor
    Comments (2776) | Send Message
     
    MexCom, timing is everything!! Time to buy more VVUS!
    1 Apr 2012, 02:40 PM Reply Like
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