NorthWest Biotherapeutics Inc (NWBO)

[ou71764]

I am not embarrassed to say that I don't get what the delay is. I'll recap what I think I've seen in all the posts. You or anyone can show me what I'm missing.

1. The vaccine was only supposed to be given to patients whose tumors weren't progressing at the time they received the vaccine. So patients were either progressing or stable.

2. After the trial was started, it became apparent that there is a pseudo-progression group.

3. When the data was gathered at the first event trigger (where we are now), there was justification to recommend early approval - except there wasn't enough data from the pseudo-progression group.

4. Someone (DMC, sponsor, or both) thought the FDA might ask for data from the pseudo-progression group.

5. So rather going to the FDA immediately to apply for approval, they decided to wait a few more weeks/months to get the necessary data from the pseudo-progression group. They thought that would all but guarantee approval.

6. The time needed to get the additional data (what they are doing now) will be far less than the time it will take to trigger the 2nd interim review and wait for that analysis.

7. So what seems painstakingly slow to investors is really an accelerated process. And we'll get good news soon.

If that's anywhere near close to the argument people are making, my response is that I hope it's true! But is there is any evidence for this, other than conjecture?