Sunday, April 02, 2023 9:52:47 PM
There is no doubt that knowing all that's known today if a new trial were starting for DCVax-L it would have been done differently. There are a few Drs. willing to fight for NVCR's way of treating GBM patients, though they often don't say so. They'll say they have no conflict and recommend more testing, but I believe the regulators can see through what they're doing and saying.
It's sad, but a friend testifies in medical cases and while such people may not lie, they tell the story in the manner that benefits those who're paying them. That's what these so called experts are doing.
I believe that if the regulators ran the trials themselves the changes that were made would be little different. Pseudoprogression which can't be differentiated from actual progression completely invalidates a PFS goal. Overall survival was always a goal in the trial, and clearly it's the gold standard for judging trials. With the trial designed to cross over from the beginning it was clear that no real control group would exist for the OS goal, the trial wasn't changed to say this, it was there from the beginning. Certainly a few patients didn't cross over, but not enough to be a real control, and many very probably because they passed on before they had the opportunity to do so. Doctors who argue the trial was flawed because of this clearly have their own agenda,
Gary
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