NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

What's missing from speculations 1-10. Or which are wrong ?

So now that (https://finance.yahoo.com/news/northwest-biotherapeutics-announces-commencement-cancer-142000358.html) , first Dc Vax L production at Sawston (2/17/22) , has happened , and been announced , what’s next? 1) commercial approval in Canada and the UK before TLD and the paper .Per Liau comment 2/15/22. 2) announcement of pursuit of multi nation commercial approval under the RTOR/ ORBIS/FDA auspices., 3)TLD and the paper, 4) announcement of 10 combo trials with $MRK , which includes $500 million in upfront license fees, 5) production ramp at Sawton to 45 per month by 10/1/22.6) reimbursement applications filed in Canada and the UK.,7) Canada/ Cognate partnership to supply DC Vax L to Canadian patients.,8) NWBO / Cognate partnership announced for USA patients. 9) uplisting?,10) Flaskworks integrated into Sawston production ?

TRANSCRIPT NEEDED:"Dr.Linda Liau discussing the MOA of (https://clinicaltrials.gov/ct2/show/NCT04201873)( combo Dc Vax L plus Keytruda/UCLA, plus other agents) in (

) , but she avoids discussing results . "




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hoffmann6383 Member Level Thursday, 02/17/22 01:53:57 PM
Re: None 0
Post #
444809
of 444815
Has Flaskworks been certified?!

I think we all knew Sawston would start production soon, if they hadn't already done so. The news wasn't as much of a shock as a confirmation of the expected.

What I found to be most interesting in the press release was the language surrounding Flaskworks. The relevant language regarding Flaskworks in all previous PRs, including today, is as follows:

9-1-20
Quote:
Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies.


3-16-21
Quote:
Certain optimization work will be required so that the Flaskworks system will produce DCVax-L products with characteristics equivalent to the products made by the current DCVax-L manufacturing processes. This will then need to be confirmed by comparability studies.


5-12-21
Quote:
In addition to the MHRA submission activities, a prototype of the Flaskworks system has been delivered to the Sawston facility, and the Company currently anticipates that initial practice runs with the system may begin at the Sawston facility during the summer.


2-17-22 (Today)
Quote:
The Company plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system.


Every single prior PR that gave a Flaskwork update used terms such as "comparability studies", "certain optimization work" or "prototype". Essentially, the technology was still under development. Today's PR referred to Flaskworks as a NEW TECHNOLOGY.
Eric: In LL’s 2/15 presentation, she discusses future Dc Vax L/ Keytruda combo trials(with extra agents).My guess is that $mrk wants to be right in the middle of that.Joe

iwasadiver Member Level Thursday, 02/17/22 02:09:16 PM
Re: hoffmann6383 post# 444809 0
Post # of 444834
I don’t believe it’s certified yet. However, I’m pretty sure they’re getting ready to have that inspection any moment. They’ve been running comparability studies since summer. My perspective is that they’re either in the process of applying or have applied for certification which means they’re almost ready or ready for inspection and MHRA certification for FlaskWorks. I know that in any project management system you have several lanes of movement at all times and some lanes move faster than others at any given time and change over time. At the present I believe we’re way into the BLA creation (which will be in the 10’s to 100’s of thousands of pages), background work being done on Direct and on the next set of combination trials and/or extensions for DCVax-L, FlaskWorks, communications with CRL, etc. I feel the publication is very soon but it’s out of the hands of NWBO at this point because the authors, statisticians, outside consultants, and peer reviewers control this part of it. I believe NWBO has stuck to their plan and the fact that they’ve remained quiet despite all the noise is a testament to their maturation over the past 5 years.

iwasadiver Member Level Thursday, 02/17/22 02:33:11 PM
Re: hyperopia post# 444821 0
Post # of 444836
Good stuff hyperopia; I think you’ve hit on a very solid back story in the UK. The MHRA is aggressive and have done all kinds of things to cut the timing of approvals without giving up the integrity of the process. They simply used project management tools to get things done more quickly while also instigating programs like what you’ve provided here. I feel NWBO management has a deeper relationship with both MHRA and the FDA than most people would be capable of comprehending. Something very profound occurred just before data lock and coincided with Dr. Stupp coming on board. The paper by Pazdur et.al. Is no coincidence in my perspective and as Flipper points out Dr. Liau is back on the road pushing the narrative to colleagues. Things are aligning and I have a feeling we’re soon going to have a major sequence of PRs, today being the tip of the iceberg.