Replies to post #323423 on NorthWest Biotherapeutics Inc (NWBO)

[Basin Street Blues]

Thanks Kaosiris - well noted . !

[marzan]

omg, we see a huge reversal today then. So, it is quite true what we are seeing about the Endpoints. Great marvelous piece of work accomplished by LP et al convincing all 4 RAs agree to these Endpoints. UK and Germany are already done and now USA and Canada are a done deal, guaranteed, imo. The drug is the same; the label in both the countries will be the same. I bet they are again going to be the same here in the US and Canada; and in all 4 RAs and countries. We should see the pps pop to $10 on this kind of news because the RA approvals are a done deal already for these Endpoints; piece of cake! Congrats all Longs, you deserve such a huge reward in your life. Enjoy!

[Kam8]

Amazing post. Thanks KaOsiris

[sukus]

Yes this is amazing. Thank you KaOsiris.

[tryn2]

Great news!!!!....(-:

[CherryTree1]

Thank for finding and posting this KaOsiris

[alexander77]

Excellent!!!

[Karlchen]

GREAT NEWS FROM GERMANY - OS ENDPOINT CONFERMED ! !

presented by KaOsiris

sorry, i had to do this with appropriate HEADLINE

Revised endpoints now also updated by PEI on german part of the EU Clinical Trials Register:

clinicaltrialsregister.eu

[flipper44]

Many thanks KaOsiris!

KaOsiris Member Profile KaOsiris Wednesday, October 28, 2020 4:41:55 AM
Re: None Post # of 323454
Revised endpoints now also updated by PEI on german part of the EU Clinical Trials Register:

clinicaltrialsregister.eu

Quote:

A. Protocol Information
A.1 Member State Concerned Germany - PEI

.....

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

[FeMike]

Revised endpoints now also updated by PEI on german part of the EU Clinical Trials Register:

"Man those European government agencies sure make a lot of typos; two identical errors on the same trial? What a bunch of morons."

- LearningCurve, probably

[ATLnsider]

Thank you KaOsiris! This puts another nail in the bear thesis coffin.

[Mionaer1]

Great!

[xoma4578]

KaOsiris - great find.

Thanks.

[Bigmahalo]

Nwbo continues to thread the lei.

[Doc logic]

KaOsiris,

One quick question. Was there any trial status update indicating the hold in Germany has been lifted as happened in the UK? My guess is that has not happened yet but could be wrong and so the question. Best wishes.

[Know-Fear]

Cool.

[antihama]

Huge!!!

Well, since I bumped up against a TOS violation, I reposted w/o the offensive? language.