Here, let me synthesize this for you.
George did not say we are approved.
George emailed someone that NWBO always thought they would be approved. No duh.
George speculates, after clarifying himself after that email, that they’d want full (normal) approval, rather than an approval with tracking conditions.
I’m proposing that the way they decided to do that, even before we filed our MAA was to add a truly concurrent external control trial with truly matching control arm.
Roswell is connected with both NWBO and MimiVax, and you can go back and look if you think this isn’t correct.
After a slow start, MimiVax started seriously enrolling their (doomed imo) GBM phase 2b trial a few months after we filed our MAA in December 29, 2023 MAA.
Mimivax’s control arm had exactly the same size as DCVaxl’s original arm (if you subtract the minor number of idh mutant from our trial), it has almost exactly the same patient profile under the new definition of GBM, and most importantly, it is a concurrent non-historical trial.
July 2025, Mimivax’s principle investigator was interviewed eleven months after the study and primary endpoint completion, and stated they were still waiting for the arms to separate even though the trial had plenty of statistical power.
Mimivax’s primary results were legally due to be published August 18, 2025 on clinicaltrials.gov, they were not. BTW, the bar for success was set unbelievably high.
A few weeks after the unpublished results in the MimiVax trial, Dr. Ashkan stated a regulatory decision in the DCVax-l trial should occur in a “couple months.”
Two months later, on November 28, 2025, the CHM, based upon abbreviated minutes from the meeting, to the best guess of everybody and their grandmother, was that CHM gave a positive recommendation on the DCVax-l MAA.
One month ago, the head of MimiVax lamented in an interview that once a therapy goes from preclinical to clinical, they can’t tinker with the drug to adapt it to new findings.
One month ago, NWBO announced it is in the process of establishing its own leukapheresis clinic inside the Welback Hospital. Apparently, it started working on this in earnest around November 28, 2025.
A few days ago, MimiVax quietly announced, buried in a new trial initiation announcement for another type of cancer (a non-GBM cancer that I agree Survaxm will likely work on), that the final analysis of the GBM 2b trial had already begun. I’m assuming it started in early May. I’m also assuming they already did most of the analysis earlier in order to confirm their tumor cell type reason for pursuing NET tumors.
About the same time as that MimiVax Final analysis initiation was announced, First Berlin strongly reaffirmed its prediction that an MA decision for DCVax-l would occur in 2026.
Mimivax should wrap up its final analysis in a couple months, for a number of reasons.
That published analysis Survaxm external control arm data could officially substantiate the Concurrent criteria for DCVax-L’s QALY valuation thus increasing the survival curve separation between DCVax-l and the conclusive control arm.
Upon likely approval of DCVax-l in the third quarter of 2026, near the same time the welbackNWBO leuk clinic is likely to be licensed, NWBO will likely submit the evidence package to NICE, imo. Negotiations/Pathway for valuation with NICE would then likely occur into early 2027 with reimbursement by the second quarter.
This timeline is essentially the same as First Berlin’s timeline.
Finally, if indeed GZ’s hypothesis that we are still trying to get full approval rather than approval with tracking conditions, if I’m correct about an additional external control arm trial, then I assume that negotiation will abruptly end with full DCVax-l approval when the Survaxm final analysis completes.
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