Replies to post #394726 on NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

You stated it better than I could. Remember when so many people used to mine the Cognate job postings and others like myself urged caution, and asked tough questions like how many other clients Cognate had?

[flipper44]

The certification is for DCVax-l batch production. That’s what they’ve been using, and when completed/certified they’ll be able to (expect) initially produce 40 to 50 batches a month by September 30. Like I said, NWBO knows what’s what, I, on the other hand would be shutting down preparations if the trial failed, but I’m not in the know, and they are, and they are getting certified, planning huge expansion, and the world just changed the definition of GBM. So, yeah, you’ve gotta be ready to manufacture if you know you’re approvable. It’s part and parcel of getting approved. Looks like they don’t believe they failed.

[biosectinvestor]

Advent does not own the space or the technology. Cognate does not own or have any part in Flaskworks. Neither company does. Cognate was the source of immense, low cost funding until shorts saw the vulnerability in the most favored nation clause arrangement and unspooled that financing arrangement for NWBO.

The fact is, a lot of stories are told that are not exactly accurate. And the fact is that private equity companies often fund ancillary and supportive companies in areas that do not make sense for the primary company. It’s not a huge margin business to be the CRO, in fact, and while Cognate sold for what, a billion, that is not the real value here, it’s a distraction.

As for Advent, it really holds the human resource costs and employment risks, and not a lot else. It’s a nice way to basically isolate those costs and risks away from the IP value center here, which ultimately holds all the value and reduces the downside risk in NWBO, at least in terms of expenses.

So I don’t agree. I think it has consistently been a master stroke of planning and structuring to host those costs and the minimal upside of the CRO away from and at arms length from the Crown Jewels here.

[antihama]

Wrong. While that may sound plausible, Lykiri gave us a big clue that NWBO, and not Advent, wears the pants in the family by posting Ratan Dev's LinkedIn's resume. That shows that NWBO is signing off (and hence has ownership) on all facility/computer validations such as below

All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility. - March 16, 2021 PR

Ratan Dev

Data Integrity/CSV/Labware LIMS/Life Science/Validation Engineer Washington D.C. Metropolitan Area
Beltsville, Maryland, United States


Computer System Validation Engineer
Company Name: Northwest Bio therapeutics
Dates Employed: Feb 2020 – Present (Full-time)
Employment Duration:1 yr 7 mos
Location: MD, United States

Expertise in developing, generating and executing IQ, OQ, PQ protocols. Experience in conducting automated testing, traceability matrix and defect management. Experience in authoring, reviewing and auditing project documentation for validation protocols that includes Validation Master Plan (VMP), test plan and test cases, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Standard Operating procedures (SOPs), Process Design Document, Risk Classification Document and Validation Summary Report (VSR)
https://www.linkedin.com/in/ratan-dev-3493419a/ - post 394230

Advent, and Autolomous' LIMS system too.