NorthWest Biotherapeutics Inc (NWBO)

[Steady_T]

We have differing understandings of the situation. FDA wants to see commercial production capability that it can inspect. We agree on that.
Where we have differing views is I don't think the FDA is concerned with capacity, you do.

It appears to me that the company understands its lack of capacity to service the US market if it were to be approved before EDEN as an approved production source so it has decided not to pursue the FDA BLA until it is in a position to service the expected demand. I think that decision is a function of the lack of money available so the company is not spending on things that will not provide a rapid return.

I hope that the company starts the FDA BLA process as soon as the UK approves with the expectation that EDEN will be approved by the time the FDA acts. Of course the company knows how far along the EDEN development is and when they expect it to be approved. Based on that knowledge they will apply to the FDA at the appropriate time.