Friday, October 26, 2018 6:04:34 PM
"Question
Dear Dr. Liau: In your video last week (and also last year), your comments seemed quite positive about the patients living longer, but last week you also seemed to say that DCVax would not be able to get FDA approval. Is that what you really meant? How could that be the case if patients are living longer? Would love to have clarification on this issue
Thank you in advance for your time .
Xxxxxx xxxxxxxx
Dr. Liau's answer
Hi Xxxxxx,
Yes, the patients do seem to be living longer with DCVax; and no, I did not mean to say that DCVax would not get FDA approval. I was making the point that, whether or not the study fits a particular category endpoint, there should be a way to get approval if the data shows that the entire group of DCVax patients (in both arms) does better than concurrent/historical controls who have not gotten DCVax.
Hope this clarifies the issue.
Thanks,
LL
Linda M. Liau, M.D., Ph.D., M.B.A.
Professor & Vice Chair of Neurosurgery
Director, UCLA Brain Tumor Program
UCLA Department of Neurosurgery"
The beauty of this trial is that even LL has not expected the trial could be extended this long today when the last patient has almost been enrolled three years thanks to another Linda's stubbornness and determination, which may even provide ss differences between various groups such as the early and late treatment groups.
This will soon be an unprecedented data rich trial ever in history.
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