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Re: cabel post# 9176

Monday, 01/28/2013 9:58:13 AM

Monday, January 28, 2013 9:58:13 AM

Post# of 16750
My minimum expectation is they will mention the word 'POSITIVE' in the PR headline which would mean 33% threshold has been met (Primary end point). Not sure how much details they will share on the PR itself but expect some good Q&A session on the CC call.

If the PR is issued with simply 'improved PFS or survival', odds are it won't meet FDA SPA (aka > 33%). Hisun might still accept as long as the trial shows improvement but it's their call.