NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

QL, to throw my hat in this discussion, my angle is that an in process MAA or an approved product is indeed necessary for MIA. However, Advent applied for MIA for cellular therapies. See the press release:

MIA license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, U.K

There are indeed other approved cellular therapy products in the UK, which is what the MIA was granted on. It covers all cell therapy products, which includes but is not limited to, DCVax-L.

Manufacturing facilities are approved based on process controls. It isn’t product specific. It is categorical.

If a Ford manufacturing line gets opened and ISO comes in to certify it from a quality standpoint, they may only be looking at a line producing F-150’s. But that facility can also produce Explorers or Escapes, even though the quality inspection looked at documentation for F-150’s.

MHRA came in and looked at the manufacturing process for DCVax-L, yes. But the license doesn’t only allow them to produce DCVax-L, it allows them to produce any and all cellular therapies. Because there are indeed approved cell therapies in the UK, it is on this basis that Advent was able to get MIA without DCVax MAA being in the approval process.