what could go wrong?, page-49

"We are looking for 6 weeks minimum PFS experimental over control. With no data lock as yet a figure of 13 months has been floated - surely too good to be true. But, taking into account the various analyses that have been put forward on this forum over the past six months or so, it seems to me a pretty good bet that the 6 week PFS will be well and truely exceeded. (This is notwithstanding the possibility of one or more left field confounding possibilities.)"

I think it's fair to say that most agree PFS in the HA arm will exceed 6 weeks. However this doesn't necessarily mean the results are going to be statistically significant, if the control arm were to exceed expectations.

There's also alot of assumptions being made here by everyone, however expecting a 13 month PFS really shouldn't be one of them.

If you assume the Ironcetcan arm in the Phase 2( 2.4 months PFS), is what to expect from the FOLFIRI arm in the Phase 3. Then by ST's calculations, 13 month PFS would be an improvement in PFS of around 40 weeks!( compared with 12 weeks in the Phase 2)

The odds of HA-Ironcetcan achieving a median PFS of 13 months, in a study where the control arm PFS is 2.4 months( or anywhere within normal range) would be about 0.001. I'm sure this is not just an assumption on my behalf, and could be shown with statistical analysis. Someone call the company to clarify

If PFS in the HA arm does show an improvement of 13 months( which is greater than median overall survival in any 2nd line mCRC trial I can remember looking at), then you can bet good money that PFS in the FOLFIRI arm is abnormal aswell. Thus it's not going to help the statistical significance of the study.

13 months would more likely be the median overall survival figure( OS in the Phase 2 was 10.1 months). There's also going to be a decent number of patients who will exceed this median, especially with the increased power of the study... so some will extend out 12 months, 15 months, 18 months etc