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mcbio

08/14/12 10:57 PM

#147102 RE: biomaven0 #147099

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).

Fair points. I'm just happy 797 is back on the radar and at least a respectable shot on goal. I had considered this drug worthless not too long ago. I don't think that's a fair take now.
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jq1234

08/14/12 11:05 PM

#147104 RE: biomaven0 #147099

Good you didn't know, shouldn't believe what you read. There really isn't basis for them to make that claim. AS trial was discontinued before full enrollment after disappointing RA trial result, thus they decided it didn't work for chronic inflammation condition at that point. Now they are making claim from AS trial? Very silly!

http://investor.arraybiopharma.com/phoenix.zhtml?c=123810&p=irol-newsArticle&ID=1305781&highlight=

In addition to recent OA trial success, previous success trial involved only acute pain, consistent with the known fact of this class of drug.