Replies to post #90223 on NorthWest Biotherapeutics Inc (NWBO)

[md1225]

Thank you senti much appreciated.

[CherryTree1]

That is certainly compelling - thanks for posting.

[Sojourner55]

This is great and the clarification much needed. Thanks Senti.

[Tadasana]

Big thank you senti, LL Thank you!

[flipper44]

Thanks Senti, I thought it was something along those lines..

flipper44 Member Level Thursday, 12/15/16 05:43:38 PM
Re: hopefulsurgonc post# 89721
Post # of 90236

....Is she anticipating failure for DCVax-L? No, but she certainly points out the obvious: crossover arms can partially confound secondary OS results because the therapy is indeed effective.

No one should be surprised about this.

The trial is still blinded for both the surrogate and confirmatory endpoints. Dr. Liau is simply attempting to proactively get the discussion going in case results are such that regulators might try to throw the baby out with the bath water if OS results do not overcome the crossover. -- Flipper, December 15, 2016

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. -- Dr, Liau

[Dan_P]

Thank you for posting this sentiment stocks.

[HappyLibrarian]

Dr. Liau's comments are important and your sharing them is appreciated.

[eagle8]

Thank you so much sentiment.

You are a very reliable person in my opinion, so i believe every word you say.
This makes me feel a lot better.

GLTU

[biosectinvestor]

Thanks Senti! This is very good and exactly what I've been saying, though not with such succinct, technical terms. Excellent way for her to put it. I expect that will EXACTLY be the case. Though, as I said, I could be wrong. I think the administrative law process at the FDA will have to take normal, scientific rationality as a given, and what is in the best interests of the patients, given the disease, lack of progress in that disease and the seeming benefit.

I could be wrong, again, but I highly doubt this does not get approved, even if only for subsets of patients or only after some careful further efforts to address any remaining concerns regarding proof of anything that the FDA may want clarified further.

[H2R]

Thanks Senti

This post is to the point, as yours tend to be :) Grateful for your contributions!
Kind regards

[vator]

Wow. Thank you. Clears things up.

[Evaluate]

Per Dr Liau email:

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.

From the video:
12:50

But also there is a need for relevant endpoints. You know, median survival, overall survival at one year, or even two years, is really… may not be the meaningful endpoint for these trials. It’s really that long term tail end. The hazard ratio at three years or four years is really what we should be computing for these trials. -- Dr Liau

Perhaps after data lock the analysis will include the Hazard Ratio at 3 or 4 years ... and it might be impressive.

[jondoeuk]

''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.''

Can you please add some screenshots to prove this is true

[Pablosrv]

Thanks for this kind of posts!!

[Astavakra]

Great news, thanks! The entire answer could have been hilighted in red. But, from a portion that isn't:

whether or not the study fits a particular category endpoint

Liau makes the point in the video that the trial design is from years back. She later says that the trial design was modeled on chemo trials(paraphrase). A lot has been learned over the past couple of years about how immuno treatments cause different response patterns than chemo. This trial's outcome being determined by what is now outdated standards is the frustration, but as LL says, there should be a way to get approval if the data on the OS of the entire group receiving DCVax shows benefit over concurrent/historical controls.

[flipper44]

Just slightly different emphasis:

"Yes, the patients do seem to be living longer with DCVax," LL clarification after 12/15/2016

"The trial is still blinded until data lock, and data lock will occur when 75% of patients have an event." -- Dr. Liau, December 15, 2016

Three converging simultaneous events. Per Dr. Liau.

1. 75% PFS Events.
2. Data Lock.
3. Unblinding.

Does this preempt NWBO's December 8, 2016 attempt to obtain a current real time (aka: today) PFS count? Maybe so.

[Lykiri]

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: