I believe that most people here would agree with me that I try to be a common sense poster. I don't have a background in medicine, so I won't try to understand all that people who do understand it because of decades in medical school, or similar training have learned in all those years.
Taking a common sense approach to what happened in the DCVax-L trial I believe that by the end of the trial they had learned much about GBM, and perhaps other cancers, that they didn't know going into the trial. What they learned made it necessary to dramatically change how the trial would be done, and how it should be evaluated.
To me it's common sense that after all of this when more than double the patients who'd have been expected to live 5 years on the SOC are alive, and nothing else in the clinic is known to be creating such results, the vaccine should be approved by all regulators and adopted worldwide.
Others will argue that in doing what they've done, even though they were communicating the changes with the regulators, they've violated rules or protocols established by the regulators, they don't think that in spite of the clear benefits of the vaccine that it should be approved. I label their posts NONSENSE.
I'll be the first to concede that the US FDA has delayed many products I felt certain would be approved, but in the end all were eventually approved. I hate the fact that the FDA causes such delays and increased costs, but it's a fact of life that they do. I cannot say that in our case DCVax-L will fly through the FDA, like I believe it will the U.K. and other regulators, but in the end I feel certain it will be approved, hopefully without too much further delay and cost.
That's my common sense approach to what's happening, do you agree, or is it nonsense.
Gary
