Legend431, you said my “rationale was completely wrong.” So, let’s clarify.
What exactly do you think my rationale for DCVax-L approval is? Because it sure as hell isn’t “JAMA published the trial, therefore approval is guaranteed.” That’s a strawman—and you know it. My position has always been that DCVax-L’s path to approval is built on a multi-layered foundation:
** A rigorously executed, multi-country, double-blind Phase III trial
** Peer-reviewed survival data published in JAMA Oncology
** A validated GMP/HTA-licensed manufacturing facility (Advent)
** A regulatory submission accepted by the MHRA
** Placement on the HDC list for high-priority review
** A robust IP portfolio protecting the platform
** Strategic infrastructure (Eden) to support scale and resilience
So again, what do you think my rationale is? Spell it out. Because if you’re going to call it “completely wrong,” you should at least be able to describe it accurately.
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