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hankmanhub

01/29/22 8:48 PM

#439710 RE: meirluc #439708

Meirluc, you posted:

However, perhaps by the summer of 2015 it became clear that the survival of the Treatment group was superior to that of the Control group.



How could they determine that while blinded?
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newman2021

01/29/22 9:46 PM

#439721 RE: meirluc #439708

meirluc, you might be a genius or a good detective, however, makes sense, thanks!
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biosectinvestor

01/29/22 10:41 PM

#439730 RE: meirluc #439708

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.
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ATLnsider

01/31/22 9:36 PM

#440143 RE: meirluc #439708

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.