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Arena Pharmaceuticals, Inc. Message Board

  • scorr838 scorr838 Oct 21, 2010 12:28 PM Flag

    ARNA DISAPPROVE BUT STOCK GOES UP

    I predict it will not be approved by FDA.
    However, they will not have to go back to all the Phase III clinical trial.
    They will have to prove that the rat results are not toxic.
    Please comment

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    • You are on the right track. Except, you should have said they will have a clear path forward to approval within a six-month timeframe and that would have made your post even more on track. Actually what will be proven is that the rats died from toxicity not from cancer and that there is no cancer risk with humans period!

      Go to the DeepCapture site for the letter that explains all of this.

    • I am not so sure ARNA will be given the chance. The only real substantive accomplishment our protest has to point to is that one of the obesity advocacy groups wrote a petition to FDA that does not seem to have garnered much attention. Outright disapproval looks to me to be the FDA's prefered outcome (why else go to such extraordniary lengths to poison an Advisory Committee meeting?) and nothing has happened to change that trajectory.

      • 1 Reply to chrisoverb2002
      • I usually don't comment on stuff like this; but in this case, I think there is overwhelming evidence to suggest that FDA will not flatly turn down Lorcaserin.

        1. Even in FDA's words, it is "minimally meets" the efficacy standard set.

        2. There were concerns raised (whether valid or not is to be seen); these concerns can be investigated and either validated or found to be unsubstantiated.

        Because the drug overall is safe, and meets efficacy standards, FDA has much less to lose by not turning it down, as opposed to closing the door completely.

 
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