NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Lykiri,

You realize, of course, the response you received from MHRA, if true, would make NWBO’s comment, that commercial MIA authorization is a prerequisite for an MAA submission, a fiction.

Here is the relevant part of the response you received.

This (MIA) application can be made at the same time as the MA application so long as there is an intention to manufacture product at the manufacturing site.

Richard Parker
Senior GMDP Inspector
Inspection, Enforcement and Standards

MHRA, 10 South Colonnade, Canary Wharf, London E14 4PU

() are mine

I await an answer from the MHRA to confirm this.