Replies to post #497035 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

You just made up your own definition of “separate.” Instead, separate simply means an MIA is not an MA. You must have both to commercially market a product.

The recent delay has all been on the manufacturing side. NWBO should have nothing holding it back from now filing an MAA. In fact, they’d be delaying the MIA if they don’t file it soon, because the MHRA must be assured that NWBO is intending to market their ATMP. The MIA is only a 90 day process.

550 SOPs have been written to get this all done.

The manufacturer licence will be granted first providing the product is in the process of being approved.
https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences