Biotech Values

[iwfal]

SNTA -

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%).

I wouldn't describe setting the endpoint of the ph iii portion as 'changing the endpoint' (from ITT to something else) since effectively the ph ii portion and the ph iii portion were always two separate trials but with some unifying portions (like trial sites?)

As for the size of the subgroups - agreed that were the efficacious subgroups small enough it won't make the ITT stat sig even if the subgroups have spectacular efficacy. But the powering numbers that they have given out imply the KRAS subgroup is fairly large - hence the question. But note that even if the subgroups drove the overall trial to be stat sig, if the non-sub-group portion had lousy efficacy it isn't clear it would be worthwhile for SNTA to enroll those patients in the ph iii.

PS Today my oscillation is that the primary subgroup is KRASm (for a variety of reasons) - but then I cannot explain the powering or the INFI results. Bottom line - enough conflicting data that I'm just going to wait and see.