Replies to post #804543 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

It is not a requirement for approval. It is new framework . Doesn't mean you couldn't get approval under previous framework . 

[flipper44]

This also transpired in last couple months.


1. Ten year data from last randomization reached, thus increasing reimbursement amount potential for DCVax-l.
(November 6, 2025)

2. QALY threshold officially raised, effective date April 2026, thus increasing reimbursement amount for innovative medicines.
(Announced around December 1, 2025)

3. UK will substantially reduce clawback tax to innovative drug corporations, thus making it cheaper for them to do business in the UK. (Announced December 10, 2025)

4. Tariffs removed by USA on therapy exports to U.S. from the UK.
(Announced December 10, 2025)

All these rapid and monumental changes that took place over just 34 days can make reimbursement feasible for companies like NWBO. Their timing demonstrates peak efficacy, higher valuation and lower tax environment. No better chance for success over the past 10 years than right now.

What recent actions did NWBO take to also make feasibility possible?

1. Reducing manufacturing costs by merging NWBO and Advent Bioservices.
(Announced October 24)

2. Initiated construction of C level clean room suites to install more cost effective Flaskworks devices for further scale up down the road.
(Announced November 20)

3. And now, also meeting the latest initial MIA certification requirements (December 15) for future expansion at some point with closed system units. Albeit, they still will need to complete c level clean room construction and post-approval comparability testing. For now, commercialization is supposed to start with artisan manufacturing.