It's rare that I believe you've written something that's worthy of comment, but in this case, at least in part I believe you're right. I wasn't involved with the company back then, but I suspect that you're correct that roughly 5 years ago the company determined that the trial as originally designed would fail. It would fail because they didn't know about pseudoprogression or how to differentiate between it, and actual progression going into the trial. Too many people, both dead and alive at that point were viewed as having progressed, though many lived on when they weren't expected to.
At that point I believe they made a determination that O/S, which would take additional years of trials, could prove the benefits of the vaccine, whereas PFS which could shorten the trial, could result in its failure.
Dr. Liau or the company are not at fault in the design of the trial, there is no way they could have known about what was learned in the process of doing the trial. What they did do was adapt the trial to one which not only should work, but the data it produces on O/S should be so clear that no one can deny the benefits of the vaccine.
In the past I've seen many drugs fail and be totally abandoned that very probably could succeed in a better designed trial. The problem is financing an additional trial, and many small companies just can't afford it. In that the genesis of most drugs is well over a decade from the time it fails, much new technology exists by the time of the failure. While a better designed trial may succeed, other drugs are now priority, if they have the funds to advance anything, so the failed trial results in the abandonment of the drug. NWBO recognizing 5 years ago that a change in direction was needed, or it would fail isn't bad management or science, it's good, they made a modification to make it work.
Gary
