NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Here are the ASM questions as they stack up at this time. I think they are pretty well vetted by now, so we can probably start voting on them.

Ike, I'm thinking everybody vote top 5?

The numbers have changed from my previous list so please respond to this post.
Let me state that no questions are bad questions. What we are looking for is to submit the top ten that the majority of us on this board would like answers to. Please everyone who reads this board and would like certain questions addressed... VOTE! :)

Ike will take over from here. :)

1. (Jack2479)
The relationship between Advent Bio - a private company owned by Mrs Powers and Northwest Bio - a public company with Mrs Powers as the CEO sits uncomfortably with many shareholders. Especially as Northwest funds were used to acquire the site and essentially build the manufacturing facilities. The lease is in the name of Northwest Bio. Notwithstanding the need to keep commercial contracts secret can you explain to shareholders why it serves our best interests to have Advent Bio independently market themselves from their website as follows -

“Advent Bioservices began activity as a cell therapy contract development & manufacturing organisation (CDMO) in 2016. We are currently currently managing the development of a state-of-the-art facility for multiproduct GMP production outside Sawston in Cambridgeshire, which will allow scale up of current commercial production and initiate the provision of contract manufacturing services to meet the growing demand for such services in the UK.

The Sawston facility is located just 7 miles outside Cambridge city centre with excellent transport links to Central London, London Stansted airport and it is 4 miles from the M11 motorway, linking to the Midlands by the new A14 extension.

The facility consists of GMP lab space and process development and additional areas for future expansion. Initial construction work has focused on the building of 2 separate GMP suites with grade B/C classified areas, in house QC testing and office space as well as a multipurpose cryogenic storage unit.

We will operate the facility under a comprehensive IT infrastructure including eQMS and an eBMR, with a LIMS with secure storage for client documents and paperless systems. Clients Operations within these suites will benefit from already validated cleanrooms, in-house environmental monitoring system as well as training, ancillary services and technical support inclusive of process development and validation. The cryogenic facilities are available to external clients as off-site storage and offer disaster recovery services as per UK regulatory (HTA) requirements.”

There is what appears to shareholders a potentially obvious conflict of interest between our CEO and a private company she owns and it’s relationship with Northwest Bio and the facilities they own. My question is -

What good reason is there why Advent Bio is not a full 100% subsidiary of Northwest Bio? Why is it in our best interests to have our CEO independently own it?

2. (Exwannabe)
Could you describe the relationship with Advent at the Sawston facility? I.E., who owns the equipment, Northwest or Advent? Could you explain in some detail how Advent will pay for the use of Sawston? Will NWBO have to pay Advent to reserve capacity for the production of DCVax, and if so, why? Is Advent free to use the facility to make product for other customers as they wish?

3. (branko, longfellow, kabunushi, ae kusterer, ahp) to replace 2, 5, 8, 12
When do you expect Sawston to be equipped, licensed, and operational?

To what extent will an operational Sawston allow for increased manufacture of DCVax treatments, prior to marketing authorisation, so that treatments can be provided to individual patients on reimbursed compassionate use programmes, such as the UK Specials scheme?

How many operating cleanrooms, and how many individual patient manufactures can be achieved per month in the pre-approval period, to service patients who have eligibility under a special programme?

Can you give us a projection on how many reimbursed treatments it is anticipated will be done at Sawston per month before approval, and to what extent this will be greater than the temporary manufacturing site in London?

And can you give an indication as to how this might translate into revenue for NWBO?

4. (IkeEsq)
What if any impact is Covid-19 having on this process or NWBO in general?

5. (Vator)
Still wonder about the colorectal Mainz trial. Did work take place? If not is it planned in the future? The hospital was supposed to fund it. What happened?

6. (Senti, aph 123, Pablosrv)
When will data lock take place, and how long after that can we expect top line to follow? We have heard that it could between two weeks to two months after data lock before we could receive top line data. What are the reasons it could take up to two months?

7. (ae kusterer)
Now, please tell us with a "ramp "in production in process , how many patients per month will be paying $200,000 when the "ramp" is complete?

8. (reg 2015)
On such and such date, (the latest available from our reporting agents in the blinded/blended phase III DCVAX trial) how many are still living? Please tell us date and #.

9. (hankmanhub)
HOW MANY ARE STILL ALIVE TODAY?

10. (ahp)
What is the financial plan?

11. (H2R)
What is the status of the SAP?

12. (StockFollower)
Why would Dr. Duffy set up a clinical trial with Merck if he did not believe in the science of DC-Vax?

13. (Lykiri)
Can Linda Powers confirm that the Autolomous employees (https://www.autolomous.com/) have been working with Northwest Biotherapeutics on developing & deploying their AutoloMATE eBMR solution (Phase 1) and that the Autolomous team are NOW busy working remotely, building Proof-of-concepts with Northwest Biotherapeutics and developing the next stages (Phase 2 and Phase 3) of their AutoloMATE platform?

14. (Lykiri)
At the beginning of the year, important information about the future of Northwest Biotherapeutics in the UK was available on the following website: https://www.mill-lane-sawston.co.uk/.

Was Northwest Biotherapeutics one of the initiators for the construction of this website and why is the information currently not available?

15. (Lykiri)
On March 16 there is a new ‘Handelsregister–Bekanntmachung‘ ( Commercial Register Announcement ?) of Northwest Biotherapeutics GmbH.

Can Linda Powers give us an update of what is going on in Germany (the German subsidiary NW Bio GmbH)?
Is Fanny Schömann still the German representative and what is her relationship with Advent bioservices? (If any, but IMO there is evidence of that relationship)

16. (Lykiri)
Late summer 2016 Linda Liau announced that 331 patients have been enrolled in the trial.

Why has Northwest Biotherapeutics waited three months to officially disclose this important information? (https://nwbio.com/nw-bio-provides-update-about-phase-3-trial-of-dcvax-l-for-newly-diagnosed-glioblastoma-multiforme-brain-cancer/)

17. (Sojourner55)
Did you extend the trial so long due to the 17 less control patients and/or crossover confoundment? Are you waiting for a certain number of events to be more assured of a separation between your control and treatment arms?

18. (manibiotech)
How about giving us the reason for the "screening suspension" or "screening hold" for the trial that began some time in the Summer of 2015?

There is absolutely no reason not to disclose it now as it can not affect the trial integrity now.

19. (Sukus)
How many employees does Management plan to hire next year?