Replies to post #428113 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

They already had the ability to produce DCVax for the UK under the specials program, now they are certified for an entire factory that is currently at 5% of its floor space using old technology, but that can be scaled up depending on demand. No regulator does that for a product not approved anywhere if they are thinking this is a useless or dangerous product or that their citizens will be ripped off hundreds of thousands of dollars for snake oil.

[Lykiri]

This is not a certification specifically to produce DCvax.

Femike,

Wrong.

It is a certification specifically to produce DCVax products.

2. Know your limits

The activities you are requesting to be included on the licence application or variation should reflect current reality and not future aspirations! The Inspector will expect to see that you have the necessary procedures, control systems, equipment and expertise to support the range of products and activities you are proposing to include on the licence.

Activities that you do not have capability to perform will need to be removed from the application before it can be approved. Such changes create extra work and result in delays in processing applications.
https://mhrainspectorate.blog.gov.uk/2017/01/05/helping-us-to-help-you/

[MI Dendream]

How certain are you of this statement?

Pump the brakes on this logic. This certification is in no way, shape, or form tied to DCVAX in that way.

They are allowed to produce DCVax under this cert. This is not a certification specifically to produce DCvax.

I will give you that it may not be limited to DCVax-L, but are you sure that it isn’t the process of manufacture that is certified in addition to the facility? That process is unique to DCVax. I would double check some of your logic and/or assumptions.

Seems to me we got Human Tissue Licensing Authority license to handle human tissue, we got Medicine and Healthcare Products Regulatory Authority certification to produce DCVax in Sawston, and we got MHRA certification to monitor, store, and supply chain manage the process for DCVax in the UK.

Any guess at what comes next across the pond?

[Fireman02360]

Pump the brakes on this logic. This certification is in no way, shape, or form tied to DCVAX in that way.

They are allowed to produce DCVax under this cert. This is not a certification specifically to produce DCvax.

It is for production of:

This is the one of the most absurd statements I have ever seen, and I have seen quite a few in regards to sowing uncertainty in regards to Northwest. Let me guess its for Stem Cell research or something?

Of course it for DCVAX, and you know it. Don't try and spin this any other way.

-Fireman