Aptose Biosciences Inc (APTO)

[dcaf7]

To prove that your combo works, you need to have a control arm. In our case, you need to run a trial comparing Tusp+Ven vs Ven alone. In APTIVATE trial you will be able to compare Tusp+Ven vs Tusp alone, not the same. You won’t see a contribution of Tusp, only a contribution of Ven. To judge how combo works, you will need to use some historical controls, an approach that I don’t like. FDA doesn’t like it either. Eventually, you will need to run a Phase 3 trial with Ven arm or completely different arm to find whether Tusp works or not. Unless, of course, the results of APTIVATE trial are spectacular and mind blowing.