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acgood

05/08/12 8:26 PM

#141604 RE: iwfal #141598

The SNTA subgroup analysis is for mutant KRAS.

Thanks as always for your statistical contributions.

I don't even think INFI dreams of filing based on the ongoing docetaxel trial, but I guess we should wait for the results first. And they did make it OS endpoint.

Summer2762

05/09/12 12:59 PM

#141641 RE: iwfal #141598

So if the HR for those two subgroups is <0.5 and there are 100 patients enrolled then as long as the 15-30 pct remainder isn't hurt it might well be stat sig.



If that were the case, they would not have changed the primary end point the trial. Thus, as a logical inference, a) either the p value of the two subpopulations is ~0.05 so that 15-30 pct remainder make a difference or b) the % of patients in these two subpopulations is not large (say < 50%). This inference, of course, depends on the assumption that the co wants to pr that the P2 portion of the GALAXY trial met its primary endpoint and that's why they changed the primary end point of the trial.