NorthWest Biotherapeutics Inc (NWBO)

[Red_Right_Hand]

That's right. Too much is being made of the Q&A at the March MHRA board meeting and/or it's being interpreted out of context. No one in the March MHRA Board meeting said any applications were being referred to the CHM for refusal. They said a small number of backlogged applications that have major objections which preclude approval are going through CHM and as soon as the outcome is clear from the CHM meeting, that outcome will be communicated to the applicants. This was said in regard to backlogged MAAs. We then we saw an email from MHRA shortly thereafter indicating that NW's MAA was not considered to be a 'backlogged' application. So this Q&A exchange on at the March Board Meeting has nothing to do with NW.

All that said. Refusal of an MAA by the CHM is how MAAs are refused approval, whether they are backlogged or not. We know from public records that MAAs go through a CHM meeting at least once and normally twice (see TVoPs analysis). We know NW had their first CHM meeting in June 2024. We don't know whether NW has yet had, or will have, a second CHM meeting. In the end, if the CHM advises refusal then the MAA will be refused (most likely, assuming the MHRA adopts the CHM recommendation which they do not have to do). This is the normal course of the process. The Q&A in the March Board Meeting didn't change that normal process, except to indicate that the MHRA was dealing with the existing MAA backlog by issuing final dispositions (i.e., refusals as recommended by CHM) in order to get the long-lingering backlogged MAAs off their docket (of which NWs is not one).


MHRA Board Meeting - 18 March 2025

Transcript

2:40:09
Thanks, Alison. So, if we move on to another pre-submitted question which is for Julian to answer.
2:40:16
This one is about the publication of the information that all new licence applications
2:40:25
received since the 1st September are being processed within expected timeframes.
2:40:31
The question is whether this means that the MHRA are prioritising applications
2:40:37
submitted after the 1st September over those that may be in backlogs?
2:40:46
Thank you for the question. We have covered this a bit today in Board in terms of what we're looking at,
2:40:52
but I'd like to reassure that we're not prioritising new applications over backlogged applications, so that we have written individually to all companies
2:41:04
with outstanding applications within the backlog recently and some of them,
2:41:12
a small number, have got major objections which do preclude approval at this stage
2:41:17
and they are going through CHM, our Commission on Human Medicines, and as soon as the outcome is clear from the CHM meeting, those will be communicated
2:41:28
to the respective companies. We have put in place new communication routes, so just looking at how do we communicate
2:41:36
and with additional resources in that vein to ensure much more transparent communication
2:41:43
and as the numbers in our backlog have significantly reduced, it's a much more manageable way of ensuring that we have effective communication with companies.
2:41:54
But thank you. Thanks, Julian.