NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Meirluc,

When Sawston was approved for commercial production originally, it was a different submission that did it. I'm uncertain if they wanted a change to that approval that it would be done in the MAA, or if they'd submit an amendment to the original submission. In my mind I'm guessing that before asking to use the EDEN, it would need to go through some sort of certification program, hopefully acceptable to all regulators. Once certified, converting existing facilities to it shouldn't be a major issue as the device is already certified. I have no knowledge of precisely how this would be done, but I would hope such certification is underway.

I believe that when the FDA receives a BLA and establishes a PDUFA date the FDA will send inspectors to the commercial production facility specified in the BLA at a date they'll established. By that time, if production will be done with the EDEN unit, it should already be certified so that the inspectors are checking the total production facility, not certifying the EDEN at that time. Of course this is JMHO.

Gary