Biotech Values

[iwfal]

SNTA - Regarding reasons for stating:

SNTA telegraphing that the ITT population PFS benefit won't be stat-sig at the interim

small number of events make such an outcome unlikely anyway

The subgroups that SNTA is talking about (KRAS wt and Squamous?) could, in aggregate, make up 70-85% of the total nsclc all-comers population. 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. (Note that this is why I noted in an earlier post that INFI might actually have the ability to file first with their ITT trial which ends in Dec 2013 per clinicaltrials. If the FDA is willing to accept just 1 randomized trial labelled a ph 2.)

no statistical/significance phrase ever used in any of the commentary (subsets or otherwise)

No, nor would I expect it when no official word is going out - but PFS HR<0.5 is stat sig in the KRAS wt population out of 100 all-comers.