I thought I'd just list the questions here so we could see what's moving forward to the company without having to look back at the original set of questions. I think this is an excellent series of questions and I hope they are able to answer them for us as thoroughly as possible.
Question #1
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?
Question #2
11. (H2R)
What is the status of the SAP?
Question #3
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?
Question #4
9. (hankmanhub)
HOW MANY ARE STILL ALIVE TODAY?
Question #5
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?
Question #6
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?
Question #7
20. (Photonic5)
Is the company purposefully delaying unblinding of the P3 trial due to disagreements with regulators over endpoints and trial analysis? If so, how long is the company willing to wait on datalock and unblinding if no agreement can be achieved? Indefinitely?
Question #8
21. Have you had any discussions with other parties regarding either partnership or buyout? If so, what can you tell us about that?
Question #9
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 #.
Question #10
10. (ahp)
What is the financial plan?
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