NorthWest Biotherapeutics Inc (NWBO)

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Can we assume $NWBO should be among hundreds of companies which filed for CNPV pilot program? The announcements will be made within weeks. Only five companies will be selected. The competition will be tough. But there are no other companies that have the treatments that can make stage IV cancer patients have pathologic complete response with no surgery, no chemo and no radiation.

Assume LP did file for CNPV pilot program, this could explain why MHRA hasn't granted the approval yet. Did someone mention before that MHRA had cleared backlog? US taxpayers spent hundreds of millions of dollars on the fundamental research of DC vaccine. All those trials at UCLA, May Clinic, UPenn, Moffitt Cancer Center were sponsored more or less by NCI. A breakthrough treatment of this magnitude has to be approved by FDA first. IMO, the merger of Advent Bio could be something related to the announcements on CNPV pilot program.

New FDA approval pathway for n-of-1 therapies coming soon, Prasad says
https://endpoints.news/new-fda-approval-pathway-for-n-of-1-therapies-coming-soon-prasad-says/

At last week’s event, the FDA’s Center for Drug Evaluation and Research Director George Tidmarsh also said that “hundreds” of companies had already applied for the Commissioner’s National Priority Voucher (CNPV) pilot program. The non-transferable voucher will be awarded to up to five companies to speed up approval timelines.

“Look forward soon to an announcement of the initial batch of accepted applications,” Tidmarsh said.

US FDA’s First Commissioner’s National Priority Voucher Class Coming Within ‘Weeks’
https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/us-fdas-first-commissioners-national-priority-voucher-class-coming-within-weeks-RBO7FAVBPVHR3PT25LKZHK7II4/

US FDA’s First Commissioner’s National Priority Voucher Class Coming Within ‘Weeks’ — Click image below to read more! || #PinkSheet | Start your free trial today: https://t.co/T0XutAYaUP https://t.co/fhsY6SzpDj

— Pink Sheet, Citeline Regulatory (@PharmaPinkSheet) September 11, 2025

The first class of participants in the US Food and Drug Administration’s newest expedited review program should be announced in the coming weeks, Commissioner Martin Makary said.

Tidmarsh said that he and Center for Biologics Evaluation and Research Director Vinay Prasad, who also has been renamed FDA CMSO, are “closely involved” in selecting candidates and “assessing and shepherding these programs through the review process.”

“You’re going to see amazing meaningful treatments I believe within the next 1-2 years that is going to blow people away…

https://rumble.com/v6ypmbe-youre-going-to-see-amazing-meaningful-treatments-i-believe-within-the-next-.html

FDA Commissioner @DrMakaryFDA talks about promising treatments in the pipeline and the innovations and breakthroughs he’d like to see in the future. pic.twitter.com/KdJKF8QB0w

— U.S. FDA (@US_FDA) July 11, 2025

Excited for the new National Priority Voucher pilot program! pic.twitter.com/YsIciT0f5P

— Dr. Marty Makary (@DrMakaryFDA) August 21, 2025