NorthWest Biotherapeutics Inc (NWBO)

[OncoJock]

My limited understanding of the current regulatory situation is that pharmaceutical manufacturing and marketing are 2 different activities, with different approvals required from the MHRA, which is roughly the British equivalent of the US FDA.

MIA (manufacturing approval) is required from MHRA before Advent, operator of the plant in Sawston UK, is permitted to make any sort of advanced medicinal product (including murcidencel) for commercial sale in the UK. In a press release, NWBO has said it expects this approval to be received before the end of this year.

MAA (marketing authorization) is required from the MHRA before NWBO, owner of the patented process for making DCVax-L, may offer the product for sale to patients or anyone else (including hospital formularies) in the UK. NWBO has not given any indication of when this approval may be obtained, nor even if an application has been submitted or accepted by the MHRA.

Reimbursement for the cost of buying DCVax-L (to patients, hospitals, or anyone else) by the UK's National Health Service (NHS) is a whole other kettle of fish that can't even begin until after DCVax-L has received marketing authorization by the MHRA.

At least, this is my perspective from the left bank of The Pond. I am not a resident of the UK.

-- OJ