NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Unless I'm mistaken, we must file on Phase 3, I don't know if we can refer to what's been accomplished in Phase 1/2 Trials. If I'm right about that, Poly-ICLC and Keytruda won't even be mentioned. We more than doubled the OS at 5 years, I believe that should easily be sufficient to grant approval. No doubt the regulators know what's being done in earlier stage trials, they know that patients will be able to use other therapeutics off label, and frankly a physician that failed to do so could be guilty of malpractice.

I don't believe we'll have a problem with approval, the only question will be the label, will it only be GBM, or brain cancers, or tumor agnostic. I believe all brain cancers may be covered, especially since GBM was redefined during the trial, so some patients who benefitted had cancers no longer considered GBM.

Of course I may be completely wrong, the company might include not only all the data from UCLA, but all that's been gathered up from the UK's compassionate use program. This could appeal for the tumor agnostic label and if achieved would be huge. My concern about such an action would be, the regulator doesn't accept it, and if that were the case, they might not accept the entire submission and demand another one based purely on results of the Phase 3 trial.

I believe the company has been working close enough with all the regulators to know what they should, or shouldn't submit. I don't know what that is, but I believe the company does. If after approval there is any doubt about using Poly-ICLC and/or Keytruda with DCVax-L I believe small, registrational Phase 2 can be run to prove the validity of using these drugs and achieving a new label.

I frankly can't say that the makers of these drugs won't prefer to spend their money in trials that expand the use of DCVax-L and their products into other cancers, not just GBM. Perhaps it all can be incorporated into one, larger, Phase 3 trial.

Gary