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Re: mcbio post# 147097

Tuesday, 08/14/2012 10:38:55 PM

Tuesday, August 14, 2012 10:38:55 PM

Post# of 257438

ARRY's prior 797 trial in ankylosing spondylitis tested the drug out to, and showed durability on pain to, 85 days



I didn't know that - reduces my concern considerably. Much more likely the CRP tachyphylaxis issue was specific to inflammation in RA then.

If they don't have new safety issues and the QTc issue isn't too serious, then this has the potential to be a very big drug. But as I said before, safety trials will need to be very big and multi-year. After Vioxx, the FDA is likely going to want a cardiac outcomes study prior to approval. (I really wonder if NSAIDs could get approved in today's environment).

Peter

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