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NeurogesX, Inc. (NGSX) Message Board

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  • nomoneyhomeboy nomoneyhomeboy Jan 27, 2012 1:08 PM Flag

    Buy...Good DD Part III:

    -The company did not conduct the clinical trials the way that the FDA would have wanted them done. The studies were combined to show statistical significance.

    -The company met statistical significance on only one of the three endpoints even though the one was the most important in that it demonstrated efficacy (NPRS score).

    -Addressing a 30 min application (new) where the FDA might want to see more clinical data before granting approval.

    Thats a little worrisome, imo
    look what happen to cbrx

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • Agree in your point of view. And it is important to anlyse all the positive and teh negative points.

      Qutenza(R) (capsaicin) 8% Patch for HIV-Associated Peripheral Neuropathy (HIV-PN)this has "Priority Review", FDA Priority Review status is given to drug candidates that offer significant advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from 10 months to six months, wich is the case.
      And note that NGX-4010 efficacy was superior to placebo regardless of sex, baseline pain score, or duration of neuropathy.

      Regards

 
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