NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

As I understand the UK operation post approval, I believe that everything supporting the manufacture, storage and distribution of the vaccine is centered around Sawston doing it with manual manufacturing. If this is the case, any inspections needed prior to approval should be in Sawston.

There are many different types of inspections.

Certainly Advent will be inspected to see that the process they will be using correctly manufactures per the submitted CMC section of the MAA,

There are also inspections of sites to verify GCP (Good Clinical Process), but more importantly as a QA check on the records.

What I do not know is LC;s question. Do they verify that the trial manufacturing sites used a process that is the same as the process described in the CMC section? They have to have some way of insuring they do, but do not know if that is a site inspection.