NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I strongly believe the UK regulators intend to say yes, however that yes will be on their terms, which still are being established. I believe that NWBO is negotiating to attempt to essentially kill two birds with one stone.

There is little doubt, as ATL indicated, they can supercharge their vaccine with the technology they've acquired. The cost could be doubled if they're forced to run confirmational trials with the current vaccine and must begin new trials with the supercharged version. Hopefully they're in the process of reaching an agreement, and I don't know how far they must go to prove the supercharged version is safe to exchange for the existing vaccine.

The cost of future trials may largely be based on what's demanded by the regulators. How NWBO pays for it may depend on stock appreciation, partnerships, trial co-sponsors, etc. What NWBO and the regulators agree to will have much to say about this.

The wildcard, or course, could be an early settlement of their spoofing case, that could preclude the need for certain actions to get more trials going.

As always, IMHO, the EDEN approval is critical to approaching other regulators. Whether any of the delays have been due to the EDEN is unclear, but regardless, during the year and a half the UK has been working on this, the EDEN development is advancing.

Gary