NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Pyrrhonian,

First of all I agree that FDA would not cause a temporary halt of a trial just because commercial scale manufacturing was not in place. That would be an issue only if a BLA was in place and the company was waiting on a response which would include a review of manufacturing preparedness. The question about the temporary screening suspension had to do with another issue then unless we know for a fact that a BLA is in place. The problem is we don't know for a fact that a rolling BLA is not in place since FDA keeps requesting additional information.

The real wild card here is how the pseudo progressor trial might fit into everything. Something was changed there very quietly and without any fanfair which is highly uncharacteristic for NWBO according to the bears aND many longs wold also agree. We know that they were going to be added into the Phase 3 results if the Phase 3 could pass muster on its own. Are we waiting on trending results from the Phase 3 to do this and response from a petition to use these combined results without finishing the planned enrollment? This may not involve a BLA if the pseudo trial was halted for positive ethical reasons but then again it might right?

Another point about early vs late tratment data being uniterpretable is pure speculation on your part. If later patients are doing better than earlier ones they would dig to find out why not condemn the trial. Best wishes.