Replies to post #417820 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

May be they want to also include the data for the "real" (non-IDH mutant) GBM. DCVax-L is efficacious in the case of the "real" GBM. Nothing else has worked.

[CrashOverride]

IDH mutations were not even known when the trial began. All tumor samples from patients were frozen during the trial. They were subsequently sequenced so their clarification can be done.

[iclight]

Takes a lot of analyses when you are mining the hell out of data to find anything positive.

[HappyLibrarian]

This is an a sadly interesting find.

I suspected that data lock might not really mean data lock, and it seems I might have been right to be skeptical.

For me, it was hard to place the blame for a delay of so many months and now a year just on the slowness of a journal (especially when you are offering said the scoop of the century, or at least the half-century because of our ostensibly excellent data for an almost invariably lethal disease).

It seems NWBO's researchers are still looking at samples and using that data to inform TLD and this has created delays because if it is not informing TLD then this should not be a factor in imposing a delay.

[biosectinvestor]

They are not. Your post is completely false and I just posted why. If you need the link, here it is:

From April 2020:

“The Company has been working since last year with the contract research organization (CRO) that managed the trial and numerous independent service companies to make the final in-person monitoring visits to all the clinical trial sites (hospitals) across the US and Europe, and to finish collecting and confirming the Phase 3 trial data and resolving queries.

Despite nearly two months (during March and April to date) in which hospital trial sites stopped allowing in-person data monitoring visits and became too overwhelmed to continue helping with data confirmation, the Company’s data collection and confirmation process has continued moving forward in part through workarounds.

The data collection process is including certain epigenetic and genetic information that is recognized as important in Glioblastoma, such as MGMT methylation status. As part of this process, the Company has also identified a method that can potentially enable an additional important genetic factor — IDH mutation status — to be analyzed using bio samples collected years ago during the trial, and to be analyzed in the same timeframe as the data lock. This IDH mutation factor was unknown when the Company’s trial began and through much of the trial period, but has become recognized as very important in recent years.

After factoring in the March and April shutdowns, and the additional genetic analysis, the Company believes it can reach data lock by approximately the end of May.

Upon reaching data lock, the data will be unblinded to the independent statisticians (i.e., the statisticians will be given access to the trial database containing all of the raw data points). The Company will not yet become unblinded at this time.

The independent statisticians will then use the raw data to calculate the relevant measures, such as median survival times and survival percentages at various time points. The statisticians will also calculate various statistical measures and prepare graphs and tables. This work is anticipated to take several weeks. The Company will become unblinded when it receives these results from the statisticians.

The Company will then discuss the information from the statisticians with its expert advisors, including its Scientific Advisory Board and the Steering Committee of the Phase 3 trial. Any questions or comments raised by the experts will be addressed and the results will be prepared for public announcement.”

[antihama]

Now if they had quarterly CCs maybe they could provide a simple explanation but now we are left to wondering about it.

[Sir Pumpernickel]

I don’t even understand what you are asking and for that matter I don’t think YOU understand what you are asking. Analysis is analysis. Some are more complex than others. Can you clarify what you are looking for or asking?
Pumpernickel YuYU.... YuYU... YuYUYuLAYUuuuuuuuuuuuu...AAAAAAAAAAAAWWWWWWWWWWHHHHHHHHHHOOOOOOOOOOOOOOOOOOOOEEEEEEEEEEEeeeeeeeeeeeeee!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[Sir Pumpernickel]

After you “lock” data you analyze it.

[skitahoe]

I believe we need to look back to when the trial began to recognize just how complex the data acquired in this trial will be to analyze. To begin with, how many patients in the trial would no longer be deemed to have GBM. No doubt, those who aren't currently considered GBM patients are still deadly sick, they're in need of treatment, probably benefit from the vaccine, but perhaps in a very different protocol. Secondly, pseudoprogression wasn't known, how many were deemed to have progressed that really pseudoprogressed. How many patients passed on without IDH being identified, because it wasn't known, but where they're working to identify it after the fact. Finally, these things were known when the trial was halted, after the trial resumed, and surgical techniques were also improved, shouldn't the 100+ who entered the trial after the halt be treated as a separate subset to really determine just how effective DCVax-L can be in this protocol.

While I certainly believe that DCVax-L should be approved in the trial protocol, given the trials at UCLA and elsewhere it should be clear that other protocols using it will improve on its overall performance. Dr. Liau will probably keep working on GBM till better than 90% become long term survivors, and based on her recent presentation, DCVax-L will still be part of the protocol then.

When Dr. Liau helped develop DCVax-L I wonder if she had thoughts at the time that it could be one of the keys to treating many forms of solid cancers. I wasn't involved with the company back before the trials, if anyone was, I'd like to hear if Dr. Liau ever expressed the belief that this might be far bigger than GBM or brain cancers in general.

Some people say that the basic science behind DCVax-L was done by others who've been awarded the Nobel Prize. I'm sure that's true, but without Dr. Liau's efforts I wonder if their efforts would have brought a vaccine to fruition. I think that Dr. Liau's efforts are certainly worthy of review for another Nobel, if they say no, fine, but I believe that she's worthy of the nomination, and then it's up to the committee that make the selection.

A member of my high school graduation class has receive the Nobel Prize, I spoke more with him at a class reunion than all my time in high school. Until then I never realized all the benefits the winners receive, it really is a monumental award that follows you the remainder of your life. Let's get the vaccine approved, let's see how many cancers it's really effective for, and then perhaps a decade or so from now, Dr. Liau will properly be considered. If DCVax-Direct has a similar impact, perhaps Dr. Bosch should be alongside Dr. Liau.

Gary