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Wednesday, January 23, 2019 11:14:17 AM
What you hilighted is key to understand why cel sci is considered as a risky "stock". Because little improvement is required to get it marketed (eg 10% better survival) it can only be proven statistically in a large population, eg only be proven in phase III.
Phase II was very limited but that's how all phase II work
Phase II had no placebo arm. True but how can you compare a 10% improvement on a very small population. Basically in phase II you could only do a qualitative assessment : total responders, reduction in tumor size, etc.. and say that's what we wanna see in a larger scale.
That's what Cel SCI did and with such challenge to prove that the drug works as pre-treatment to SOC there were little other ways to conduct a phase II.
So when Feurstein said "phase II don't prove anything", he is right but like in most of phase II, that's why there is a phase III for drug marketing approval !
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