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Incyte Corporation Message Board

  • jacosa jacosa Nov 16, 2012 11:46 AM Flag

    Nov 13 ACR webcast

    Finally got around to listening to it. Good enough efficacy (in the old days it would have looked incredible; we're getting spoiled). Fantastic safety results. Something that will probably be talked about more is improved stiffness on waking--it's an important thing for patients, but it may also confound other subjective endpoints.

    The p3 design is typical for a large pharma. They don't want to risk having to go to FDA a second time, so they're doing some extra trials and running the key ones a little longer than a smaller, hungrier company would.

    We ought to get a pretty good idea how things are going within 18 months. Time to approval (presuming success) will depend a bit on how tofa does--worst case would be if tofa shows magnificent activity but a lot of ill-defined safety problems. Best case is tofa about as good as a biologic but moderate well-defined safety issues (especially drug metabolism interactions and some sort of infection issue of the same severity that tofa showed in its p3). Roughly 3 years at best to 4 at worst. I think we can rule out an infection problem with bari severe enough to block approval, but it would be REAL helpful for eventual market share if it remains better than tofa.

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