NorthWest Biotherapeutics Inc (NWBO)

[Clippr]

Hi,

Did a little digging myself and came to this (same) conclusion too: This should be the authorization for commercial manufacturing by the facility. Next up should be the application for regulatory approval for DCVAX-L by NWBO
That's my understanding.

2022-07-06 : Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility

https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility-301581737.html

The application builds upon the 3 licenses received for the Sawston facility in 2021.

2021-09 : 1- The first license was received in September, 2021, from the Human Tissue Authority of the UK, and provided authorization for collection and storage of human tissues (such as the tumor tissue used to make the lysate for DCVax®-L products) and cells (such as the immune cells used to make DCVax-L).

2021-12 : 2 & 3 : The second and third licenses were received in December, 2021, from MHRA, and provided authorization for manufacturing cellular therapies for use in clinical trials and compassionate use ("Specials") cases, respectively.

2022-07-06 : Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility

The next step for this license application will be another on-site inspection of the Sawston facility by MHRA – this time, inspecting the facility, its procedures, personnel, regulatory documents, capacity and capabilities in accordance with the standards for commercial manufacturing. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA.

Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.


2022-12-19 : Authorization / License received for commercial manufacturing. (https://cms.mhra.gov.uk/mhra/mia/uk-miaimp-54923)


Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself.

The Company has not to date (in july this year) submitted an application for commercial approval of DCVax-L.


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So, (to repeat) all this is about the facility.


Mid this year, the facility applied for a commercial manufacturing license and they expected to receive that this year end after previous successful steps. What we saw should be just that, authorization/the license to commercially manufacture.

Next up should be the application for regulatory approval for DCVAX-L by NWBO

That's my understanding.