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.
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.
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