Biotech Values

[The Danish Dude]

Yes, we are way past coincidences at this time.

During the last 80 days, MHRA have instigated three "things" in the UK that directly points to the curriculum of DCVax-L.

1)
Point of Care framework.

https://www.gov.uk/government/consultations/point-of-care-consultation/consultation-on-point-of-care-manufacturing

Introduction
Technology is enabling the creation of new types of medicinal product that have features such as very short shelf lives and which may be highly personalised, requiring them to be manufactured and supplied at the point of care (POC).

And DCVax-L will be automated, scaled and manufactored by Flaskworks.

https://nwbio.com/northwest-biotherapeutics-announces-presentations-on-dcvax-l-personalized-vaccines-manufacturing-and-scale-up-and-dcvax-l-clinical-program/

2) MHRA to receive £10m from HM Treasury to fast-track patient access to cutting-edge medical products

https://www.gov.uk/government/news/mhra-to-receive-10m-from-hm-treasury-to-fast-track-patient-access-to-cutting-edge-medical-products

The funding over the next two years will support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the UK’s healthcare priorities, such as cancer vaccines and AI-based therapeutics for mental ill-health.

Next two years there are only ONE cancer vaccine. So this has NOTHING todo with mRNA cancer vaccines estimated around 2030.

3) MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years

4) UK has build a new cancer excellence center for paediatric clinical trials 90 miles from NWBOs headquarter in Cambridge.

NWBO will start two soon

https://nwbio.com/northwest-biotherapeutics-announces-approval-of-pediatric-investigation-plan-pip-by-mhra-pip-approval-is-a-pre-requisite-for-application-for-approval-of-a-new-medicine-for-adult-patients/

As well as paediatric trials for DCVax-Direct was already planned in 2019

https://nwbio.com/update-on-dc-vax-at-asco-2019/

EBCI will use their advocacy efforts towards FDA approval.