AI
Tuesday, December 30, 2025 12:01:58 AM
Gro,
Did you hear the CEO today? She specifically said they have not filed YET but will following MHRA’s decision. Having the first approval is a key step…
She outlined the very intensive & expensive process of engaging a team of consultant experts for 🇬🇧U.K. before redirecting resources to filings in both
🇨🇦Canada & the 🇺🇸U.S.
She also alluded to the evolving regulatory environment & reminded us that NWBO is developing platform product candidates beyond DCVax®-L. Both DCVax®-Direct & Roswell’s aDC1 are included in the pipeline!
Concurrent with the MAA review, manufacturing is advancing, & the FDA is moving toward more modern & innovative regulatory policies. The conditions & timing of a BLA might just align to NWBO’s advantage & there may soon be another BLA candidate in addition to DCVax®-L.
The FDA’s recent statement represents a real shift in the 🇺🇸U.S. regulatory environment, & the FDA has also stated their intention to further expand the new guidance.
FDA Press Release
Excerpt Source
There are multiple trials relevant to NWBO that include either a DCVax product or Roswell’s aDC1 platform.
Beyond the PIII ECA, DCVax®-L is also being studied in a RCT setting with placebo group.
For details about the DCVax®-L PIII clinical trial, the most comprehensive resource is the independent peer review that was published in JAMA Oncology.
R&D is very costly. UCLA & Roswell have won competitive public grants awarded & renewed by NIH & DoD which have only further validated proof of concept, need, & prospective value of DC platforms in the rapidly expanding field of immuno-oncology.
The FDA is increasingly recognizing that targeted immunotherapy COMBOS are rapidly evolving to become the standard of care for many cancers, & PD1 blockade already is part of the SoC for many cancers.
FDA Immuno-Oncology
The Immuno-Oncology Therapeutics Program (IOTP) will foster:
Next Generation Dendritic Cell Treatments
AACR IMMUNO-ONCOLOGY CONFERENCE 2026
Did you hear the CEO today? She specifically said they have not filed YET but will following MHRA’s decision. Having the first approval is a key step…
She outlined the very intensive & expensive process of engaging a team of consultant experts for 🇬🇧U.K. before redirecting resources to filings in both
🇨🇦Canada & the 🇺🇸U.S.
She also alluded to the evolving regulatory environment & reminded us that NWBO is developing platform product candidates beyond DCVax®-L. Both DCVax®-Direct & Roswell’s aDC1 are included in the pipeline!
Concurrent with the MAA review, manufacturing is advancing, & the FDA is moving toward more modern & innovative regulatory policies. The conditions & timing of a BLA might just align to NWBO’s advantage & there may soon be another BLA candidate in addition to DCVax®-L.
The FDA’s recent statement represents a real shift in the 🇺🇸U.S. regulatory environment, & the FDA has also stated their intention to further expand the new guidance.
FDA Press Release
Excerpt Source
There are multiple trials relevant to NWBO that include either a DCVax product or Roswell’s aDC1 platform.
Beyond the PIII ECA, DCVax®-L is also being studied in a RCT setting with placebo group.
For details about the DCVax®-L PIII clinical trial, the most comprehensive resource is the independent peer review that was published in JAMA Oncology.
R&D is very costly. UCLA & Roswell have won competitive public grants awarded & renewed by NIH & DoD which have only further validated proof of concept, need, & prospective value of DC platforms in the rapidly expanding field of immuno-oncology.
The FDA is increasingly recognizing that targeted immunotherapy COMBOS are rapidly evolving to become the standard of care for many cancers, & PD1 blockade already is part of the SoC for many cancers.
FDA Immuno-Oncology
The Immuno-Oncology Therapeutics Program (IOTP) will foster:
Next Generation Dendritic Cell Treatments
AACR IMMUNO-ONCOLOGY CONFERENCE 2026
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.
