Replies to post #315347 on NorthWest Biotherapeutics Inc (NWBO)

[hope4patients]

Very interesting!!

[Sojourner55]

Excellent find ATL. Thanks

[marzan]

hmmmm great finding ATLnsider. You must be something! You broke the SNO Late Breaker news too I think. No wonder Les keeps saying on those shows we are going to UK first. They are waiting for the data ever since they gave us the Priority Designation or so. I heard patients are waiting and the list goes for 6 months. Cheers!

[ATLnsider]

You're all welcome. I think the endpoints may have been changed because of the revised SAP.

If I remember correctly, all of the 4 regulatory agencies (USA, UK, Germany & Canada) were submitted the same revised SAP. I believe NWBO got buyin from all 4 RAs.

This could be a mic drop moment...

[marzan]

Interesting to read Primary Endpoint will be evaluated in October 2020. So, TLD in October is guaranteed. Someone here thinks TLD closer to SNO 11/20; but I don't think so.

[Just1guy]

I don’t recall what the EU trial said before. This seems strange to me.

“ 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.”

Has it always been they will compare OS treatment group to control groups that received SOC in different trials?

The second through fifth Secondary endpoints specifically compare the treatment to control group within this study.

“The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.”

Regards

[flipper44]

Many thanks.

[sharpie510]

NWBO is also going for approval in recurrent GBM according to the first secondary endpoint. And the placebo crossover patients will be compared to comparable patients OUTSIDE of the trial.

Even for the second secondary, PFS must be CONFIRMED PFS (cPFS) = ADJUDICATED PFS? This is looking really good.

E.5 End points
E.5.1 Primary end point(s)
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.
E.5.1.1 Timepoint(s) of evaluation of this end point
October 2020
E.5.2 Secondary end point(s)
The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.

The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.
E.5.2.1 Timepoint(s) of evaluation of this end point
October 2020

[anders2211]

Thanks. I noticed dr Bosch mobile phone is in there as well. Perhaps I will give him a call tomorrow..!

[abeta]

ATL

Great Find.

Thank you very much.

regards

[Dr Bala]

Great find. Thanks.

[Lykiri]

ATLnsider,

Wow, thank you!

Today the German version has not yet been adjusted but I expect an adjustment one of the following days.

E.2 Objective of the trial
E.2.1 Main objective of the trial
The primary objective of this study is to compare progression free
survival (PFS) between patients in the DCVax-L cohort and patients in
the placebo cohort in patients with no evidence of disease progression at
baseline.
E.2.2 Secondary objectives of the trial
The secondary objective of this study is to compare Overall Survival (OS)
between patients in the DCVax-L group and patients in the placebo
group in patients with no evidence of disease progression at baseline.

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE#summary

[MI Dendream]

In addition to switching the primary to OS, it looks like the secondary is now confirmed PFS (cPFS - i.e., adjudicated PFS) rather the the former straight PFS.

So this is why it took so long to get the SAP done! This is vey good news. Perhaps this also explains the long delay in DL. Maybe they still had dome things to iron out with FDA.

[Uranium]

ATL, Looks like your discovery may have shaken some buyers loose

[Chiugray]

ATL Thanks! Very good information.

[kabunushi]

God damn ATL, this is dynamite!!!.

Now it's time for ExW and all the smart and not terribly smart naysayers to put their heads together and denounce the hell out of this, claiming that they could not possibly have changed the trial endpoints, these endpoints (comparison to SOC in other trials) cannot possibly be accepted by the FDA or any other regulatory authorities etc. Oh yes and also and especially restate their claim that IA looks were already done long ago and failed which was kept secret as they have always claimed and especially of that fake 'fact' this SAP is meaningless BS. Go ahead, waiting to hear from you ExW!

[eagle8]

Thank you ATL.
Great find !

GLTU

[abc1212]

Thanks ATL, great find

[br8k0ut]

Good eye! Thank you!

[rogers5729]

Really cool find. For those interested in comparing what the page looked like previously, here is the only archived version I could find (from 2013):

https://web.archive.org/web/20130125171343/https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB

[sentiment_stocks]

Looks like the cat's outta the bag as to the pathway the company plans to use to file their BLA.

This particular pathway presents a way to more easily achieve statistical significance with the data, and does away with the messy explanations about pseudo progression that might have had to accompany a top line PR that the market might not have initially understood. That's my thinking anyway.

Thank you for staying on top of this ATL and alerting us all to this very exciting bit of news. :)

[hyperopia]

WOW!! THANKS ATLnsider. This is really huge news!! There will not be any ambiguity in the results, which was my biggest concern. I’m not really surprised by this news, as I’ve said that I think the primary endpoint would be changed to OS, but having this confirmation before TLD is VERY VERY good to know.

[maverick_1]

SUPERB Sleuthing vs all the pre 2018 high profile prolific scientific posters in NOT uncovering what was KEY to

Clearly REVISED SAP approved by all 4 Regulatory Agencies many years ago.

SAME analogy applies to ALL those other NWBO super critical historical inflection points:
1)Why buy Sawston, UK: weeks of lots of flack/consternation/bewilderment
2)Why biggest NWBO lawsuit emanated from UCSF: UCSF felt threatened.. lots of illustrious alma mada types in IMMUNIOLOGY like Merck's EVP Roger Perlmutter etc etc
3)Why CEO Linda Powers secured husband and wife team (CLONES of her to fill the dual roles of prep and fill up senior mfr ranks of Cognate BioSciences that was sold on a MBO!
4)Why no one in the UK ever posted about the sheer concentration of Chinese mainlanders both having their bright one's studying at Oxford Univ and owning real estate nearby to result in Huawei building their largest non China campus via CEO Linda Powers pulling out the BIGGEST of many rabbits Out of the Hat: her Biggest financial Saviour from Near Ashes
5)No others here even sensed Cognate BioSciences would be sold!
6)292,000 Well heeled UK investors got fully skunked and will not be able to source their DECIMATED funds till year end 2020 .. ALL caused by fully disgraced and supposed NWBO long term financier: Neil Woodford who received glowing adoration here!
7) Hats off to Longfellow's knight in shining armor in joisting AND verifying UK likely to give DC VAX L approval.
7) VP David Innes has no prior professional experience in the field of Investor Relations unlike what has been expressed: POSTED
9)BTW selling is NEVER a good nor reliable prognosticator re BasinStBLUES multi year torments here on CEO Linda Powers who did it for TAX Reasons by sustaining a GIGNORMOUS LT tax loss on NWBO to OFFSET her WHOPPING LT Gain on Cognate BioSciences: previously posted but BSB has been unaware or intentionally omits THE FACTS..not seeing The WHOLE LOAF (THE BIG PICTURE vs an incorrect vignette) has been my experience here since 2014. It's all in black and white for every poster.

The above are what comes to mind!

BOTTOM LINE!:

HISTORY has demonstrated that there are boatoads of ILL equipped NEOPHYTES with empty bravado and only posting on ONE company and rarely with supporting links .... GLORLLA glueD!

Some even said Corona Virus would not persist in tropics: see Brazil's Covid-19!

Obviously none of this could have been achieved if it wasn't for The SUPREME NAVIGATOR, extraordionaire... CEO Linda Powers who along with SVP Les Goldman have BOTH received SILOS of MANURE since 2015 and some even demanded her being ousted in late 2018-2019!

Moving ON vs dealing with recalcitrant, circuitous, deflections ala DT types!

NO major US Stimulus plan happening since late July especially as it relates to 5th largest economy that of traumatized California State, even NY State which the former had to raise their already highest personal income state tax rates is a harbinger of both The EXTREMES of Capitalism
are rampant where health care, housing and educational costs are financial crippplers causing this: The 50 Richest Americans Are Worth as Much as the Poorest 165 Million where 50% of US population only have 2% of all wealth re today's
US Federal Reserve:A MUST READ:

The 50 Richest Americans Are Worth as Much as the Poorest 165 Million "https://www.bloomberg.com/news/articles/2020-10-08/top-50-richest-people-in-the-us-are-worth-as-much-as-poorest-165-million";

DIFFERENT STROKES FOR DIFFERENT FOLKS

[snoopycomic]

Thank you for the good detective work

[spidaman]

Awesome find ATL!

[Hansm7777]

Excellent find ATL. Every day is now getting more and more exciting. Just fabulous news. Thank you.

[ATLnsider]

Another thing that is really interesting, is the EU clinical trial register clearly states that both the OS and the PFS will be evaluated and disclosed in October 2020 (this month).

Some here are speculating that we will not get TLD until November, but it looks like we should get TLD in October:

https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/GB#summary

Go Braves!!!

[CherryTree1]

WOW . . . WOW . . . BIG BIG MEGA-WOW

Did everyone read this:

E.5.1 Primary end point(s)
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.

E.5.1.1 Timepoint(s) of evaluation of this end point
October 2020

We don't even need the unblinded topline data with this as the criteria. They already passed this criterial BIG TIME with the still blinded data.

I can't believe Linda was able to get this as the Primary End Point . . . WAY TO GO LINDA . . . HAPPY ALMOST BIRTHDAY !!!

Thanks for finding this and posting this ALTnsider !!!

[Kam8]

Dear ATL, Amazing post. THANKS

[ccie1024]

Thanks ATL. Nice to get caught up on what Dr. Bosch is up to over there...

:)

[HappyLibrarian]

Post of the Year goes to you.