NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Lyriki, one of the possible alternatives myself and a few others tossed around some years ago was that the last 31 were being used as a bridge study to possibly confirm any optimized manufacturing process. Your find shows how such a methodology was publicly accomplished with another company. One of the clues that might lead us to this speculation with NWBO was the attention drawn once 300 patients were enrolled. Another clue was the attention drawn to the German optimization and previously to the patent improvements (example: tangential flow filtration) that one would be hard pressed not to incorporate over this length of time. Another clue was the further partial enclosure of steps in the process along with companies that helped Cognate keep the blood chain supply completely enclosed. Anyway, there were many more possible clues that made it a reasonable possibility. Many years ago Dr. Boynton was hopeful they could wait on any manufacturing optimization (because of the delay it might cause), but it’s reasonable to guess that perhaps they didn’t wait to place optimization into the mix.

If that group was not randomized, and they did somewhat better than the earlier treatment patients, it is easy to see why NWBO would also need historical comparisons (as well as trial comparisons) as part of the narrative.