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VIVUS Inc. Message Board

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  • nhji87 nhji87 Mar 29, 2012 4:54 PM Flag

    CNBC IS NOT SURE!

    I confirm CNBC does not know. NOBODY KNOWS!

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    • why the heck would anyone listen to a tv show for information like this.

      • 1 Reply to imos461
      • well it really is quite simple. This panel recommended by an overwhelming vote to RECOMMEND to the FDA that pre approval studies be done if there is a cardiac signal and post approval if there is no signal. This should apply to VVUS because it did indeed have a signal and the CRL noted it. Same for OREX. ARNA's candidate had a large study population with no signal and was not a concern in the CRL. It will probably do a post approval study and should offer to do one at their ad com. If they don't offer it will probably be a requirement for approval. The FDA can ignore the recommendation all together,ignore it for the current candidates and apply it to any new ones, or break protocol and require all currently unapproved candidates to do pre approval studies. They will do what they want but they have favored VVUS so far and this is in their favor.

 
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