NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Thank you so much, beartrap12, for such a thoughtful and detailed comment. What you wrote makes perfect sense, and I agree that everything you mentioned could very well be happening in real time. The February 2024 press release strongly supports that view. It explained that Advent would complete GMP validation of the Eden automated manufacturing system and then submit data to regulators for approval of its use in production. That means Eden’s qualification and installation could already be advancing in tandem with the MHRA review without needing to wait for a later audit window.

That is also entirely consistent with what kabunushi shared after speaking with GV. He simply confirmed that Eden is not folded into the current DCVax-L application. That does not preclude Eden following its own regulatory path at the same time. In fact, this approach fits the company’s earlier plan: DCVax-L approval first, Eden ready for integration once its GMP validation is complete. Either path works because Advent can always produce the vaccine by the manual method until Eden is cleared.

As for DocLogic’s earlier point, the UCLA paper was not about developing synthetic immune cells that must be trained to recognize self from non-self. It was a physics-based demonstration of how mechanical forces such as stiffness, shear, and viscoelastic relaxation govern immune activation. Those same parameters were detailed in the Flaskworks Eden patents years before. Eden applies those mechanics biologically, using each patient’s dendritic cells pulsed with that patient’s tumor lysate, meaning they already distinguish self from non-self naturally. The biology has already been proven. Eden-generated dendritic cells show strong, synchronized IL-12p70 and TNF-a release, the hallmark of Th1 activation and potency.

To restate, my earlier narrative was never about regulatory timing. It was about how UCLA’s viscoelastic APC study validates Eden mechanistically, while Eden itself has already proven the biology. Both perspectives fit together perfectly, and the conversation here shows why this kind of detailed, fact-based discussion matters. I appreciate everyone’s insights.