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Where will biomarkers be used most?

biomarkers Used
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Where will biomarkers be used most?

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I think everyone agrees this is anything in the cancer area right now. If we are going to have biomarkers and do patient profiling, this is the area we think can have a more immediate impact than on some other diseases. So when I talk to people, I think that’s their area of focus, where they said we could really see [opportunity] from a commercial standpoint. [It’s] how you can actually get products to market, because the FDA is also very interested in moving things forward quickly with cancer-fighting drugs. The regulatory pathway seems to be a little quicker. What’s your take on FDA’s recent guidance on submitting PGX data? Most of the initial comments I’m hearing from the industry are that FDA really stopped short of actually giving definitive rules and guidelines. So they’re [FDA] saying that this is the kind of data we want, but you know what they really said was still wide open as to interpretation. Are they going to require it for all NDAs or not? What is the crucial path for ap

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