Replies to post #775344 on NorthWest Biotherapeutics Inc (NWBO)

[laser777]

Take that and spin it FUDSTERS!!!!!

[seekinganswers]

You may want to look into this... My last email response referred me to the variationenquiries email of MHRA.
https://www.gov.uk/guidance/medicines-apply-for-a-variation-to-your-marketing-authorisation

The MAA is apparently in variation status, or else why would they refer me there? No clue yet as to what variation they are seeking. Could be PIP trials, manufacturing process, formula change... who knows.

[DrHigh]

thanks for sharing the follow up communication

[JTORENCE]

StonkMaster OK Time to start the spin:
So does this mean that the disposition has been provided to the company and they can do what they want with it. I thought the MHRA would announce to the public (via their website) of their disposition to the application.
Or am I reading this from a different perspective then the statement was intended to convey?

[Lykiri]

I received the same response myself about an hour and a half ago.

Thank you for your continued correspondence.
As previously communicated, we are unable to comment on applications during the process of review. We have only confirmed the presence of this application as we are aware of the information the company has publicly released online: Northwest Biotherapeutics Northwest Biotherapeutics Announces that a Marketing Authorization Application has been Submitted to the UK MHRA For DCVax®-L for Glioblastoma - Northwest Biotherapeutics
Our comment previously was to indicate that this with the company to comment; it is with the company to determine the appropriate information for sharing.
We remain focused on delivering medicines and medicinal products which are rapidly assessed for quality safety and efficacy.
If you need to contact us again about this request, please quote the reference number above.
Kind regards,

Angel
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, London E14 4PU
Telephone [phone]

.

July 07

Dear MHRA Customer Experience Centre,

I am writing in follow-up to my previous enquiry regarding the DCVax-L marketing authorisation application, registered under case number CEC 220399.

In your response, I was informed that the MHRA cannot share information regarding ongoing applications without the company’s consent, which I understand and fully respect.

However, I have since seen a response from your team under case number CEC 225494, in which the following statement was made:

> “The application is not backlogged and is with the company.”



A copy of this reply can be found publicly here:

$NWBO received a second email from the UK MHRA from a previous email
I send them. Here is the email I received this morning when I asked a follow-up question about the MAA being backlogged pic.twitter.com/zIZx3ypFl0

— AJW (@ajw02360) July 6, 2025

I would appreciate it if you could kindly clarify the meaning of the phrase “is with the company” in this context, as it may be interpreted in different ways. For example, does this indicate that the application is paused awaiting a response from the company (e.g. due to a regulatory ‘clock stop’), or that the MHRA has completed its part of the assessment and the next steps lie with the sponsor?

Additionally, could you confirm whether the same status applies to the DCVax-L application referenced in my original query under case CEC 220399?

Thank you in advance for your time and assistance. I remain grateful for the vital work the MHRA carries out in the interest of patient safety and access.

Kind regards,