NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

When you look at what LP said at the last Annual Meeting she indicated that we'd be a very different company by the end of this year. Even without the approval, we have changed dramatically in terms of what we should be worth, sadly investors haven't yet seen it that way. In time they will.

I still believe the odds are a little better than even that we'll get the approval before the Annual Meeting, that should turn the year quite profitable at practically the last minute. If not, LP's words I suspect will be a positive, in that annual highs are just over $.40 we could close the year at a new high without the approval. That would set us up nicely for an approval early next year.

As .for the FDA, relax, they need to see a production facility that supports their manufacturing requirements, and now that means a closed system, IE the EDEN. We may not need it operating the day a BLA is filed, but roughly 3 to 4 months later the inspectors will want to inspect the facility. With the cleanroom/EDEN facility due to be completed during the second quarter of next year, the earliest we should file a BLA would be in the first quarter of the year. Of course, this assumes the no multi-national approval is currently being considered.

I'm of the belief that with UK approval several other countries potentially could piggy-back on the approval, but capacity limitations until the EDEN is available will limit how many patients could initially be treated. Hopefully if the demand is there, many EDEN units will be ready in the new cleanrooms on their acceptance, and perhaps even some spoke organizations will immediately be established.

We're currently over IOWA heading toward Chicago, so a little over halfway to NYC.