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Saturday, November 14, 2020 1:31:34 PM
Linda Liau responds to investor concerns regarding 12/15/16 Seattle presentation. In an email exchange between an investor and Linda Liau, Dr. Liau offers clarification regarding her comments from the presentation.
Quote:
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
Sent from my iPhone
Sentiment,
It is interesting that Linda Liau made an allusion to today's new endpoints back in late 2016.
The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.
LIVE Q&A - Brain Tumor Treatments & Advancements
We were LIVE on Facebook with Charles Cobbs, MD, Director of the Ben and Catherine Ivy Center for Advanced Brain Tumor Treatment and Linda Liau, MD, Director, Brain Tumor Program, UCLA School of Medicine taking all of your questions about brain tumor treatments & advancements.
Linda Liau min 26.30:
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