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mcbio

07/10/12 6:48 PM

#145282 RE: jq1234 #145275

They said no OS benefit trend for FR++ sub-group either. Someone can correct me if I am wrong here.

I think the most important point of all is that ECYT has disclosed that PFS benefit alone will support approval, at least in the U.S. (#msg-70634907 ). As I've noted before, if no OS benefit is shown in Phase 3, that would obviously strengthen the need for very robust PFS results.

I think most updated OS results were reported in the PR I cited in #msg-73232523. ECYT disclosed in that PR that, adjusting for prognostic imbalances between the study arms, OS HR ratio for FR++ group was .481. Obviously plenty of caveats in that disclosure.