Replies to post #803080 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

Wouldn’t Sawston need to be licensed to supply any living cell therapy product for any customer and trials?

[manibiotech]

Hope you are right 

[FeMike]

It’s not big.

Stop.

The pumping is insane.

[KevGee59]

I don't think this means Approval is just around the corner...but who knows? So I asked AI the difference between today's (12/15/2025) and the MIA Advent got on 8/21/2025. Just to know the difference.

Asked this: What's the difference between UK Mia 54923, investigational and UK Mia(imp) 54923, human.

AI Overview

The difference lies in the authorization type for handling investigational products in the UK: UK MIA 54923 (Investigational) refers to a general license for manufacturing or importing Investigational Medicinal Products (IMPs) for human clinical trials, while UK MIA(imp) 54923 (Human) specifies a license (MIA(IMP)) focused on importing IMPs, often from approved countries, with the "human" part confirming it's for human use, ensuring strict quality (GMP) and Qualified Person (QP) oversight, essential for trial safety. The "(imp)" signifies importation, and the core number '54923' is the unique license identifier, both under MHRA regulation.

Breaking Down the Terms:
UK: United Kingdom.

MIA (Manufacturer's Authorisation): A license from the Medicines and Healthcare products Regulatory Agency (MHRA) (the UK regulator) to manufacture or import medicinal products.

IMP (Investigational Medicinal Product): Any product used in a clinical trial, including new drugs, placebos, or licensed drugs used in new ways.

MIA(IMP): A specific type of MIA for Investigational Medicinal Products, covering their manufacture and/or import for trials.

54923: A unique identifying number for that specific license.

(imp): Denotes that the authorization specifically covers the importation of IMPs.

(Human): Confirms the license pertains to products for human clinical trials, not veterinary use.

Key Difference Explained:

UK MIA 54923, investigational: This likely refers to the broader authorization for handling IMPs, possibly including manufacturing within the UK or importing from anywhere.

UK MIA(imp) 54923, human: This is a more specific license focusing on the importation of IMPs for human trials, often from pre-approved countries (like the EU/EEA), requiring specific QP certification checks before release.

In essence, the second label highlights that this license (54923) is for importing IMPs (the 'imp') for human trials, requiring stringent oversight to ensure safety and compliance with Good Manufacturing Practice (GMP).