what could go wrong?, page-52

I love your effort ST, but I could never support your theory

Sure the trial design/ control is different, however the variance should be small and would of been taken into account with the trial design and the goals of the study which the company have set out( it would of been calculated by statisticians and should have a fair degree of accuracy) It's never going to be that great it leads to a 250% increase in median PFS from the HA arm.

So you're saying you expect a better PFS result from the HA arm in the Phase 3, compared with the HA arm in Phase 2?

I'm not sure why you would be expecting 13 months which would mean a PFS improvement of 40+ weeks when the company certainly isn't. PFS on the Phase II was 12 weeks- the target in the Phase III is 6 weeks. As allured to by Pete in the post above from TDA, they've even powered the study to be statistically significant from a much smaller difference than seen in the Phase II.

I don't have any magic figures for you, so I'm just basing my assumptions around the goals set out by the company, since that's what the study is designed around. If PFS really was 13 months, then I'd even be concerned, as it would certainly raise questions marks over the studies credibility.

There's lots of talk about data lock and how the trial has blown out past the anticipated date. However wasn't the estimated Completion date always Jan 2013? and does the trial not require secondary end points to be met before Preliminary results are reported?

"Consider if you will that "HyACT drugs are actively internalised by cancer cells, increasing the intracellular chemotherapy concentration by up to 1000 fold" (see link below). So why is a 5 fold improvement over the control arm so difficult to comprehend?"

Perhaps you should call the company and ask why they're aiming for 6 weeks and not 60?? Give em a call this morning ST.