"DCVax-L is built on a patient-specific, tumor-targeted mechanism: dendritic cells are extracted from the patient’s blood and “educated” using lysate from that patient’s own tumor tissue. These trained cells are then reintroduced to stimulate a targeted immune response—not against a generic cancer type, but against the unique antigens of that individual’s tumor. That’s why DCVax-L is considered cancer agnostic. It doesn’t rely on markers unique to glioblastoma—or any specific tissue type. It targets tumor-specific antigens derived from each patient’s tumor, regardless of origin."
yes, we know
"It was NOT a denial of DCVax-L's broader potential or mechanism of actions across caner types."
NO, not a denial of broader potential, but it is NOT what they applied for. The woman said " an immunotherapy for glioblastoma.". You can't put words in her mouth or say she meant something else.
"The MHRA cannot expand the approval of a drug for which it did not apply for. However, it can make variations to the terms of a marketing authorization (MA) if the changes are minimal in impact on the quality, safety, or efficacy of the product. These variations must be submitted within 12 months of implementation and require immediate notification if they are Type IAIN changes. The MHRA will process these applications up to 30 days"
"This isn’t speculative. The NHS validated DCVax-L’s agnostic mechanism by placing it on the High Cost Drug list—not just for glioblastoma, but with recognition of its broader potential."
This would be a major variation and would have to be PR'd.
"The question is when will regulatory agencies formally designate it as such—and expand the licensing to reflect what the science and clinical data already show. "
The answer is, when NWBO applies for it.
"Others will follow, assuming they haven't already."
other what? agencies? Once again, NWBO would have to apply to them first.
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