NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Please correct me if I am wrong, but I believe that Sawston was inspected and approved for commercial production some time ago. I don't think further inspections are required unless modifications require additional inspections.

They absolutely are required.

Inspections for GMP (which Advent has passed) say that they follow proper Quality Assurance standards. They do not say anything about the manufacturing process of the specific product.

The inspection as part of the MAA will insure that the process as used by Advent to make the commercial product is the same as the process as defined in the MAA. The process defined in the MAA is that which was used in the P3 trial unless NWBO can establish they are equivalent.

When Advent was certified for GMP it did not ,matter what the process was, as long as Advent properly executed it.