AI
Sunday, August 17, 2025 11:56:24 AM
Dg,
The key 🔑 to the U.S. market, and BLA approval:
Search FDA guidance for industry and you will find extensive info about manufacturing requirements for BLA approval. The U.S. is a big market, and the FDA requires a BLA submission to include a robust section on manufacturing. (Manufacturing was also a major sticking point in the delayed approval of Provenge many years ago, for example.)
Pages 33-34 of the Code of Federal Regulations
Title 21, Food & Drugs states the applicable requirements for BLA licensing:
The FDA requires that the BLA demonstrate the applicant can reproducibly manufacture the product at commercial scale (not only small batches). There are many citations that make specific reference to commercial scale manufacturing for BLA approval.
BLA Pre-License Inspections
MANUFACTURING ➡️ BLA ➡️ ORBIS
“Accelerated approval” is a relative term, especially for a novel cell-based platform. Generally, a drug can take decades of time and billions of R&D dollars to bring to market. NWBO has proven to be a small but MIGHTY company. They have been resilient because the science is solid, and the company’s leadership has been committed for many years. IMO, the ongoing peer-reviewed funding through the U.S. NIH and the U.S. DoD is undeniably significant and meaningful for NWBO—support and scientific validation of DC platform technologies has only increased over time.
Arguably, NWBO has doubled its pipeline and prospective value by adding Roswell Park to the equation. UCLA already had peer-reviewed grants supporting combo research with agents such as pembrolizumab, and now Roswell Park also has peer-reviewed grants supporting combo research with agents such as pembrolizumab.
The speculation about Orbis is relevant and valid—just a simple recognition of how regulatory strategy works and 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 and 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, and 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, and others.
Building on Advent’s capabilities, U.S. manufacturing and automation are logical next steps to support expansion of DCVax-L, DCVax-Direct, and 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.”
NWBO 10-Q
NICE UK 🇬🇧 DCVax-L
ASM June 29, 2024
Manufacturing Technology
AI Fact-Checking
The key 🔑 to the U.S. market, and BLA approval:
Search FDA guidance for industry and you will find extensive info about manufacturing requirements for BLA approval. The U.S. is a big market, and the FDA requires a BLA submission to include a robust section on manufacturing. (Manufacturing was also a major sticking point in the delayed approval of Provenge many years ago, for example.)
Pages 33-34 of the Code of Federal Regulations
Title 21, Food & Drugs states the applicable requirements for BLA licensing:
The FDA requires that the BLA demonstrate the applicant can reproducibly manufacture the product at commercial scale (not only small batches). There are many citations that make specific reference to commercial scale manufacturing for BLA approval.
BLA Pre-License Inspections
MANUFACTURING ➡️ BLA ➡️ ORBIS
“Accelerated approval” is a relative term, especially for a novel cell-based platform. Generally, a drug can take decades of time and billions of R&D dollars to bring to market. NWBO has proven to be a small but MIGHTY company. They have been resilient because the science is solid, and the company’s leadership has been committed for many years. IMO, the ongoing peer-reviewed funding through the U.S. NIH and the U.S. DoD is undeniably significant and meaningful for NWBO—support and scientific validation of DC platform technologies has only increased over time.
Arguably, NWBO has doubled its pipeline and prospective value by adding Roswell Park to the equation. UCLA already had peer-reviewed grants supporting combo research with agents such as pembrolizumab, and now Roswell Park also has peer-reviewed grants supporting combo research with agents such as pembrolizumab.
The speculation about Orbis is relevant and valid—just a simple recognition of how regulatory strategy works and 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 and 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, and 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, and others.
Building on Advent’s capabilities, U.S. manufacturing and automation are logical next steps to support expansion of DCVax-L, DCVax-Direct, and 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.”
NWBO 10-Q
NICE UK 🇬🇧 DCVax-L
ASM June 29, 2024
Manufacturing Technology
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.
