NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

It is my belief that all four regulators know DCVax-L far better than most products they're asked to evaluate. Remember, all four agreed to a halt and changes once the trial resumed. All four agreed to change the trial goals from PFS to OS, they understand how pseudoprogression made the PFS goal meaningless. All four agreed when Germany proposed dosing all remaining in the trial, rather than having some in the control group, they abandoned the use of a control group completely, using historical information they had available for comparison.

I would also contend that all four know about the major advancements being made at UCLA, even if no data about it is being provided. I believe that as all four approve DCVax-L they'll also encourage the use of Poly-ICLC and/or Keytruda with it, even if no official action is taken to make that happen.

I frankly wish regulators would take more dynamic actions, if they don't grant approvals where they know of tremendous benefits, grant EUA's until sufficient data exists to make it an approval, and they should work with the raw data, clinicians, etc. and not require anything like 1.7 million pages to gain an approval.

Gary