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Monday, December 19, 2016 11:54:18 AM
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
This investor doesn’t post on the boards, and decided to forward me the above email exchange with Dr. Liau regarding a question the investor had asked her in an email. The investor was concerned as a result of her Seattle presentation that Linda Liau was of the impression that DCVax-L would not be eligible for FDA approval despite the fact that these patients were all living longer.
Dr. Liau’s response to the query is important, and I don’t believe this person had actually anticipated receiving a response from her, let alone a response as quickly as it was given.
So this person forwarded the entire query and response to me because this investor felt what Dr. Liau wrote was very relevant to all other investors as well. And since this investor knows I do post on the boards, this seemed the best way to share it.
And I know a few of you will wonder why this person couldn’t just post it themselves. The answer is that this investor doesn’t post, has never posted, and most of you would not be familiar with this person anyway. The investor decided that having me post this exchange with Dr. Liau would be the best way to get out LL’s self-described clarification on this “issue” to all of us.
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