NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

I couldn’t just let this one go because it’s too ignorant to not address. NWBO filed an MAA using the approved MIA process of grade B suites manufacturing by hand. The MAA will be approved for that process. A type II variation is required to use FlaskWorks machines. That work can be started before approval and has no effect or impact on that approval. In February of 2024 the company announced that they were embarking on the next steps to have a fully GMP compatible version of the prototype made.

In their recent PR this is the particular wording:
“ The Company's business plan currently envisions manufacturing being established in the Grade C suite in the Sawston facility during Q2 of next year, with the construction of the Grade C suite taking approximately 6 months, followed by equipment installation and validation.”

“Being established” means up and running. They then say the C suite should take 6 months followed by machine installation and validation. Validation has to be done on every single machine that is installed each time they build a new suite and add new machines. However, this is different, and much simpler, than the overall validation required for a Type II Variation request. After a Type II Variation is approved all new machines have to be validated individually. This is standard GMP manufacturing stuff.

I believe it’s likely they recieved a GMP quality FlaskWorks machine back in 2024 and Advent began the required studies/comparability steps, discussed this path with the MHRA, got their advice and guidance, and set about doing the batch reports, QA controls, and all the other steps required of a Type II Variation approval. All they need is one machine to be verified in an existing C grade clean area (which they already have). From that point they can apply for the Type II Variation and once they have this all they need is to validate each new C suite that come online, and each new machine that gets installed. These last 2 items would require only about 45-60 days. Further a Type II Variation request is confidential regulatory correspondence so this could be well under way, and close to finalized.

I’d suggest you do more research before you so confidently speak ignorance