NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

I share my communication with MHRA.

Sent: 23 September 2021 15:59
To: PCL <[e-mail]>
Subject: Query about the Certification of the Sawston Facility.

Hi,

On May 12, Northwest Biotherapeutics (US Compagny) announced that they submitted an Application to MHRA for Certification of the Sawston Facility.

Registered office address:
Sawston Business Park, Sawston, Cambridge, United Kingdom, CB22 3JG

All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.

My queries:

Is the GMP application filed under Advent Bioservices or Northwest Biotherapeutics?

Who will be the owner of the CERTIFICATE OF GMP COMPLIANCE? Northwest Biotherapeutics or Advent Bioservices?

Has Northwest Biotherapeutics or Advent Bioservices submitted an additional application for a Manufacturing and Importation Authorisation (MIA) and/or an MIA for investigational medicinal product (MIA IMP)?

We are now more than 90 working days after May 7, the day that the application package was submitted to the MHRA. When will the process of Regulatory Certification being completed?

Best,

XXXXXXX

Reply this morning:

Dear XXXXXX

Thanks for the enquiry below.

Yes, we have received an application for ADVENT BIOSERVICES LTD for an MIA(IMP) license.

Their application is still currently under assessment with an inspector.

Yes, initial application could take 90 working days or longer if further enquiries are required from company.

If you require further information, we advise you contact the company directly.

Kind Regards

Inspectorate & Process licensing (OA)
Inspection, Enforcement & Standards Division

Medicines and Healthcare Products Regulatory Agency
10th Floor, 10 South Colonnade, Canary Wharf, London, E14 4PU.
Telephone: [phone]
gov.uk/mhra

This afternoon:

Sent: 28 September 2021
To: PCL <[e-mail]>
Subject: Re: Query about the Certification of the Sawston Facility.

Hi,

Thanks for the reply! Much appreciated!
I understand that the GMP application for the Sawston facility is still currently under assessment with an inspector.

I have a last question: Who will be the owner of the CERTIFICATE OF GMP COMPLIANCE of the manufacturing facility in Sawston?
Northwest Biotherapeutics, the owner of the facility in Sawston or Advent Bioservices, the CDMO who is also the operator of the facility?

Best,

XXXXXX

About 2 hours ago:

Best,

XXXXXX

Dear XXXXXX,

Thanks for the enquiry below.

The name of the company provided to us was ADVENT BIOSERVICES LTD which will be named on the GMP certificate once approved.

Kind Regards

Inspectorate & Process licensing (OA)
Inspection, Enforcement & Standards Division

Medicines and Healthcare Products Regulatory Agency
10th Floor, 10 South Colonnade, Canary Wharf, London, E14 4PU.
Telephone: [phone]
gov.uk/mhra