Replies to post #428170 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

That is not what a license says or does and you know that, but everyone knows and the license specifically references the specials regulation. That would not be the case if this was purely a CGMP license to produce any old licensed product in the UK. Additionally, in order to get THIS license they needed the license from the HTA for human tissue... if you recall. They also had to have the relevant qualified personnel for THIS manufacturing process for which they showed the relevant procedures and processes.

You think this is just a clean floors and clean hands certification? Are you trying to imply this is nothing more than a food prep license?

No one said this is a DCVax-L approval again, but everyone knows WHAT this is for, including the regulator. No one is naive here. The regulation provides for the protections that are adequate in the UK to ensure that patients receive a valid and useful treatment under the evaluation of their doctor and health facility. Doctors and hospitals in the UK that rip off their patients, or provide snake oil, will likely get in a heck of a lot of trouble in a highly regulated market like the UK. All of the pieces are being put into place for the next steps as well. The regulatory process usually wants to have an idea of the process for manufacturing, that it is consistently reproducible and scalable. That is all clearly in process and in the works, which telegraphs also that everyone is very serious here about DCVax-L.

And of course they can manufacture other products because it is now CGMP certified, for processing this product and others, that use live, human cells.

Oh, and what does this say, at the bottom of the license, and not even the most pertinent part, but quite obvious:

"Operations
Part 1 - MANUFACTURING OPERATIONS
[ 1.3 ] Biological investigational medicinal products
[ 1.3.1 ] Biological medicinal products
[ 1.3.1.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.3.2 ] Batch certification
[ 1.3.2.3 ] Cell therapy products
Special Requirements
Live Cells
[ 1.5 ] Packaging
[ 1.5.2 ] Secondary packaging
[ 1.6 ] Quality control testing
[ 1.6.4 ] Biological"

[Lykiri]

Please provide me a link showing that this is specifically and only for the production of DCVax products.

Start with this one:

BETHESDA, Md., October 28, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced the completion of two key milestones which are required for production of DCVax products at the Company’s manufacturing facility in Sawston, UK, and which have been a major focus since the completion of initial construction last year.

https://nwbio.com/northwest-biotherapeutics-announces-hta-license-issued-and-mhra-inspection-conducted-for-sawston-uk-facility/

and
Blog
MHRA Inspectorate:https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you/

etc.....