You’re correct; the evidence so far leans greatly toward success. However, as I’ve said in the past this technology is not a pill measuring the decrease in systolic blood pressure vs. another blood pressure pill. That would be a simple study and simply understood results. The complexity of the results is not one big issue, it’s in the details of who benefits most, how much that is relative to others, and relative to other similar groups in other trials. Keytruda was approved based on success in less than 15% of the trial participants because those less than 15% were essentially cured of lung cancer. It wasn’t because they progressed less quickly. Who gives a flying fuck about PFS if a certain group defies the entire Cancer and gets completely through it? PFS did not correlate to that and was essentially useless. Why stick with it if the trial shows you it’s success clearly without it, in a different manner?
In our trial they were completely upended by something they hadn’t anticipated and instead of throwing in the towel figured out how to use the evidence that presented itself in the proper way. The entire idea of mPFS itself has been controversial for years among researchers who’d rather argue fervently over minutia that is not truly clinically relevant than to step back and see the practical relevance. Eggheads in science often could draw no conclusion about anything without having others who contextualize it so that what is easy to see is explainable statistically as “Proof”. With a complex trial such as DCVax-L NWBO learned tons more over the past 5 years than in the first 12 of their existence, as was Dr. Liau in particular. If one looks at how Keytruda was able to walk away from medians in general and mPFS specifically one can see precisely how they took that same emerging knowledge from immune trials and circumvented the pitfalls that NWBO had to endure to show them the way. In other words Keytruda, via Merck, succeeded in no small part because they noticed and understood (as NWBO also was) that traditional endpoints had little utility in immune therapies because of the delayed effect. Why on earth would any company completely redesign and redo an entire trial when the data derived would be the same as the one they were already doing? It’s absurd to think you’d completely throw away everything you found simply because your original premise of showing it’s success wasn’t in fact what led you to the correct answer. That would be completely stupid.
So, anyone’s fear of “marginally good” data is simply not understanding completely that in this trial there is more than likely no such thing; it’s a home run or it’s a dud. People on DCVax either lived a lot longer over the norm or they didn’t. The only naysaying will be nothing more than what we’ve seen in politics over the past 4 years culminating in apparently sane people believing because the data showed Trump winning in the early evening proved he couldn’t have lost as the morning came, or that statistical analysis by certain people “proved” it was impossible that Biden could have won, or that if you tell a lie enough with conviction and a straight face despite what the evidence is showing you can convince people of anything if they want to believe it. The evidence will be clear. The statistical analysis has only to prove the longevity seen in this trial was because of DCVax and not due to chance. And that data will show it in many ways that make any lies or any attempts to discredit it nearly impossible. That is why we’re waiting. They’re doing everything to make this as irrefutable as possible because that’s the environment in which we now live. I believe this to be true and accurate.
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