I think we are saying the same thing, but describing the steps differently meirluc. I am explaining how randomization still occurred as to arms. But no one was started on placebo only at some date for the same reasons. I think we’re in agreement.
It was important to maintain the blind. And of course what I am saying is just a theory. I do not claim to know actually what happened, but I find other explanations create complications that are problematic and contradict other facts and circumstances in such a way that I can’t agree that those are the explanation. I am left with what I think happened. And I think we are in agreement Meirluc. Thanks for the post.
I agree meirluc, this is exactly what I have been saying. It is also consistent with what Dr. Pazdur said regarding a “lack of clinical equipoise”. It was the FDA who initiated the partial halt after it became apparent that the DCVax-L treatment group was doing significantly better than the control group.
As a result, it was not ethical to continue randomizing trial patients to the placebo.