No, you mischaracterize the details to fit your own viewpoint. Risk factors are a specific animal.
We all know about the lack of a placebo arm after everyone crossed over and recurrent patients did so well after having crossed over to get the drug. The reasons for these issues were ethical and then the learning of the pathology of the disease when confronted with a powerful immune response, as well as further then the nature of a trial for a rare disease that is almost always fatal.
The reality is, the regulators approved the various stages of the trial. The switch to OS and external placebo were done pursuant to regulations and prior to unblinding and have nothing to do with “manipulation”. Lastly, OS data is a true measure. PFS is a proxy created to allow speedier trials, and it relies on often false assumptions that PFS will cause improved survival, and frequently that is not true and sometimes the FDA revoked approvals when it turns out not to be true. That issue related to pseudoresponse.
Optune was approved based on PFS and a prediction of survival.
NWBO wrote in its interim analysis that they were looking at OS, and in fact that they were still blinded. A huge hint there about what they were working toward.
You can’t fake survival or manipulate data in a trial like this to prove a significant improvement in survival not just for newly diagnosed GBM but also recurrent GBM.
Sorry HG, it’s simply not a narrative that fits the facts.
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