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biomaven0

03/26/14 2:22 PM

#176004 RE: DewDiligence #176003

>>very strong hazard ratio (say, 0.4-0.5) on the overall-survival endpoint

Not a lot of cancer drugs (if any?) that have an OS hazard ratio under 0.5

Usually you are doing pretty darn well if you can hit 0.7 - that was what Xtandi did.

Peter
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iwfal

03/26/14 2:50 PM

#176010 RE: DewDiligence #176003

EXEL -

The failure to stop the trial at the interim analysis almost certainly rules an HR in that range (or better).



Given that EXEL probably used O'Brien Flemming interim analysis (significant majority use OBF) then we know that the HR was >0.75 (the HR they assumed when the designed the powering of the trial).