NorthWest Biotherapeutics Inc (NWBO)

[MasterKit]

I'll throw this out there one more time...

NWBO has had "Promising Innovative Medicine" (PIM) designation since 2014. According to the Guidance below, that was step 1 of 2 within the "Early Access to Medicines Scheme" (EAMS). Step 2 involves applying for a scientific opinion, and showing that, "The Applicant is able to supply the product and to manufacture it to a consistent quality standard (GMP)".

The dossier's for this pathway are to be submitted on specific dates according to the link below, one of which is December 13th. This pathway would support the reason why no regulatory submissions have been announced, and why they may be waiting for their commercial manufacturing approval to submit. This would give them a 75 day turn around on being able to market in the UK.

https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams