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Arena Pharmaceuticals, Inc. Message Board

  • fedupwithwallstreet1110 fedupwithwallstreet1110 Apr 23, 2013 8:46 AM Flag

    Why I think Belviq will get approved in EU (& CH)

    These are my latest musings on why I think Arena will get European approval. As usual, don't rely on these -- they're not investment or expert advice.

    Also, at the bottom, a few videos I just edited.

    As anticipation brews for a CHMP opinion I find myself consumed with the subject of European approval again... My gut feeling is positive and the reasons for it are:

    These are all my interpretations / opinion :

    - Arena answered 180 day questions -- EU needed outside experts to help it understand the complex data -- just as FDA needed an AdComm -- Arena worked with the CHMP and its experts along the way.

    - What are the chances that these experts gave a green flag after examining the data? That was the purpose of my call to Dr. Daniel who knows this data better than anybody outside Arena. He confidently confirmed that a real expert looking at the data will see clearly that valvulopathy and cancer are not issues. Therefore, I'm confident safety is not a concern.

    - In 2011 EMA approved a paediatric investigation plan for lorcaserin (which tells me something about safety).

    - Lorcaserin meets EMA's categorical criterion of greater than 10% weight loss over placebo at the end of a 12 month period. As a friend just put it, we would not have gotten this far if efficacy was an issue.

    - Obesity is an epidemic in most EU countries. They need Belviq and I don't see them having any good reason to reject it.
    (CONTINUED}

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