AI
Sunday, December 28, 2025 9:28:13 PM
zero82,
Thanks for asking about Project Orbis again 😶
Yes, Orbis is a real program & a real possibility. CNPV is too…
Orbis is one of several regulatory options available to NWBO or any other company. It may very well become part of the strategy for ANY of the technologies NWBO is developing…
The speculation about Orbis is relevant & valid; it’s just recognition of how regulatory strategy works & the full range of possibilities for NWBO going forward for one or more than one of their DC platforms…
Project Orbis is coordinated by the FDA, and it requires a U.S. BLA submission as a starting point. Concurrent submissions to multiple regulatory authorities can be strategically valuable for companies planning international commercialization.
Aside from the question of whether or when NWBO might pursue the Orbis route, it is a noteworthy fact that 🇺🇸 FDA chose to partner with 🇬🇧 MHRA for Orbis & MHRA’s MAA decision is certainly relevant and will have global significance—The UK is a member nation of Orbis and approval would bode well for applications in other member nations, & could influence the review timeline favorably for NWBO…
No one has insider knowledge of NWBO’s plans for how they might strategize or coordinate regulatory filings for any of their platforms. But whenever they submit a BLA for DCVax-L, Direct, or for a Roswell DC product, we do know that they’ll have the same option anyone else has to leverage Project Orbis for simultaneous international reviews. That’s a real possibility to consider as Orbis may be part of a smart regulatory plan to perhaps optimize review timelines across the U.S., Canada, Australia, & others.
🔑 Manufacturing is key…
Building on Advent’s capabilities, U.S. manufacturing & automation are logical next steps to support expansion of DCVax-L, DCVax-Direct, & the Roswell DC platform(s).
“In May 2019 Project Orbis was initiated by the FDA Oncology Center of Excellence, together with the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC). Since then, 5 other countries have joined as partners.
Project Orbis was designed to facilitate simultaneous submissions and evaluations across multiple countries to address the delays in drug approvals that can hinder timely patient access to innovative therapies.
The simultaneous submission process has led to a more efficient and coordinated review system and improved consistency in the assessment of drug safety and efficacy. The result has been the approval of 102 cancer indications in at least one additional country beyond the FDA, with 70 indications granted in at least three of the seven countries.”
Beyond Orbis, FDA’s new CNPV Program looks like another real possibility that NWBO might consider pursuing.
Commissioner's National Priority Voucher Pilot Program
Notably, a drug candidate is eligible at any stage of development, so the Roswell DC platform could potentially be eligible with PII data.
Additionally, a complete BLA package is not required in advance of an application to participate in the voucher program:
Aligning a CNPV application with the MAA decision could be strategically effective timing.
NWBO ASM December 29, 2025
ASM Zoom Link - Enter Passcode 424449
AI Fact-Checking
Thanks for asking about Project Orbis again 😶
Yes, Orbis is a real program & a real possibility. CNPV is too…
Orbis is one of several regulatory options available to NWBO or any other company. It may very well become part of the strategy for ANY of the technologies NWBO is developing…
The speculation about Orbis is relevant & valid; it’s just recognition of how regulatory strategy works & the full range of possibilities for NWBO going forward for one or more than one of their DC platforms…
Project Orbis is coordinated by the FDA, and it requires a U.S. BLA submission as a starting point. Concurrent submissions to multiple regulatory authorities can be strategically valuable for companies planning international commercialization.
Aside from the question of whether or when NWBO might pursue the Orbis route, it is a noteworthy fact that 🇺🇸 FDA chose to partner with 🇬🇧 MHRA for Orbis & MHRA’s MAA decision is certainly relevant and will have global significance—The UK is a member nation of Orbis and approval would bode well for applications in other member nations, & could influence the review timeline favorably for NWBO…
No one has insider knowledge of NWBO’s plans for how they might strategize or coordinate regulatory filings for any of their platforms. But whenever they submit a BLA for DCVax-L, Direct, or for a Roswell DC product, we do know that they’ll have the same option anyone else has to leverage Project Orbis for simultaneous international reviews. That’s a real possibility to consider as Orbis may be part of a smart regulatory plan to perhaps optimize review timelines across the U.S., Canada, Australia, & others.
🔑 Manufacturing is key…
Building on Advent’s capabilities, U.S. manufacturing & automation are logical next steps to support expansion of DCVax-L, DCVax-Direct, & the Roswell DC platform(s).
“In May 2019 Project Orbis was initiated by the FDA Oncology Center of Excellence, together with the Australian Therapeutic Goods Administration (TGA) and Health Canada (HC). Since then, 5 other countries have joined as partners.
Project Orbis was designed to facilitate simultaneous submissions and evaluations across multiple countries to address the delays in drug approvals that can hinder timely patient access to innovative therapies.
The simultaneous submission process has led to a more efficient and coordinated review system and improved consistency in the assessment of drug safety and efficacy. The result has been the approval of 102 cancer indications in at least one additional country beyond the FDA, with 70 indications granted in at least three of the seven countries.”
Beyond Orbis, FDA’s new CNPV Program looks like another real possibility that NWBO might consider pursuing.
Commissioner's National Priority Voucher Pilot Program
Notably, a drug candidate is eligible at any stage of development, so the Roswell DC platform could potentially be eligible with PII data.
Additionally, a complete BLA package is not required in advance of an application to participate in the voucher program:
Aligning a CNPV application with the MAA decision could be strategically effective timing.
NWBO ASM December 29, 2025
ASM Zoom Link - Enter Passcode 424449
AI Fact-Checking
Bullish
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
