Really Dew? You think that Kirkman would have thought there was little or no chance of seeing an HR of less than .715 at the 2nd interim? After seeing the subgroup HR in the 50's in the Phase IIb?
I think funding after the 2nd interim, which frankly seems stupid to me with all the cash they already had, says literally nothing about what the boundaries are.
I think two things:
- First, there's an inadequate understanding on this board of what "overpowering" means.... and in the context of HRs, it means that low p-values don't necessarily translate to particularly low HRs. You do get that as the trial size gets bigger and bigger, HRs closer and closer to 1 will produce smaller and smaller p-values, right? A trial of immense size could have an HR = .9999999 and a p-value of .0000000001
- Second, I really don't think Kirkman understands clinical trial statistical analysis. Not any better than your average biotech investor. He understands biochemistry, and business to some extent. His calculation of the cost of equity leaves something to be desired, I will say that.
Regards, TGW
“The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” Carlos Castaneda