AI
Sunday, December 28, 2025 6:07:45 PM
Gro,
Anyone can ask the FDA to verify the claims HyGro continually publishes online about info that the FDA has supposedly shared with only HyGro about DCVax®-L 😶
Division of Industry & Consumer Education (DICE)
1-888-INFO-FDA (1-888-463-6332)
DICE@fda.hhs.gov
Center for Biologics Evaluation & Research (CBER) Customer Service: 1-800-835-4709
CBERCustomerService@fda.hhs.gov
Fact ✅️: NWBO has not filed YET.
We do not know why there is a BLA delay, but we do know that a BLA in the U.S. is different than an MAA in the U.K., & some components of the filing package would be different...
DC vaccines are complex products, & the FDA requires GMP consistency & scalability. NWBO may still be finishing standardized automation development & validation for that part of the BLA package, & if the FDA wanted more progress on standardized automated manufacturing, that could easily delay filing.
While it true that a new drug candidate does not need huge mass production capability to be approved, commercial production must be established & observable — commercially scalable.
For a small clinical-stage biotech, manufacturing an individualized novel cell-based product is a monumental feat when it comes to commercialization. NWBO has made great progress toward that milestone achievement with the acquisition of Flaskworks in 2020 & the acquisition of Advent in 2025…
DCVax-L is in artisan production in the U.K. today, EDEN is in active development, & the Roswell products are slated to be manufactured at a site in the U.S. (NWBO has narrowed their search/negotiations to include 2 finalist GMP manufacturing sites in the U.S.)
“In 2007, Dendreon's application for PROVENGE was denied because it lacked sufficient information to prove the product's safety, effectiveness, and the ability of the manufacturing facility to consistently produce a safe, pure, and potent product.”
FDA’s Evolving RWE Stance
ORBIS & CNPV Options
What’s next?
Anyone can ask the FDA to verify the claims HyGro continually publishes online about info that the FDA has supposedly shared with only HyGro about DCVax®-L 😶
Division of Industry & Consumer Education (DICE)
1-888-INFO-FDA (1-888-463-6332)
DICE@fda.hhs.gov
Center for Biologics Evaluation & Research (CBER) Customer Service: 1-800-835-4709
CBERCustomerService@fda.hhs.gov
Fact ✅️: NWBO has not filed YET.
We do not know why there is a BLA delay, but we do know that a BLA in the U.S. is different than an MAA in the U.K., & some components of the filing package would be different...
DC vaccines are complex products, & the FDA requires GMP consistency & scalability. NWBO may still be finishing standardized automation development & validation for that part of the BLA package, & if the FDA wanted more progress on standardized automated manufacturing, that could easily delay filing.
While it true that a new drug candidate does not need huge mass production capability to be approved, commercial production must be established & observable — commercially scalable.
For a small clinical-stage biotech, manufacturing an individualized novel cell-based product is a monumental feat when it comes to commercialization. NWBO has made great progress toward that milestone achievement with the acquisition of Flaskworks in 2020 & the acquisition of Advent in 2025…
DCVax-L is in artisan production in the U.K. today, EDEN is in active development, & the Roswell products are slated to be manufactured at a site in the U.S. (NWBO has narrowed their search/negotiations to include 2 finalist GMP manufacturing sites in the U.S.)
“In 2007, Dendreon's application for PROVENGE was denied because it lacked sufficient information to prove the product's safety, effectiveness, and the ability of the manufacturing facility to consistently produce a safe, pure, and potent product.”
FDA’s Evolving RWE Stance
ORBIS & CNPV Options
What’s next?
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.
