Replies to post #663031 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Completely agree
Although Newman and Hoff and Dstock, danish may get a panic attack by realistic expectations

[dstock07734]

hyperopia,

It is a lot of work. Many thanks.

Each compassionate use case has to be reviewed by experts in MHRA separately. Given the fact that there are hundreds of patients who have received and are filing for the use of DCVax-L, MHRA certainly knows the urgency of approving this treatment. Earlier means more lives can be saved. Did NICE already have the payment plan set up for the approval?

[meirluc]

While the "highest priority" designation for this MAA is probably out of reach,
"high priority" is a probable (IMHO) because of the substantial interest in brain
vaccines expressed for years by the UK medical community and government officials

If that is correct, the latest time for approval may be August but I would not be
surprised if it comes as early as May. Hence May-August?

[exwannabe]

So why does that disagree so much with the actual 2023 numbers per the MHRA?

Figure 6 (on page 11) is for initial approvals based on MHRA only (no help from EMA/FDA/others). That would be the class -L is in.

Days from validation to approval for all 7 this year:

March. 1 approval 360 days
May. 1 approval 425 days
Aug 1 approval 400 days
Oct 2 approvals 360 days (median)
Nov 2 approvals 350 days (median)

Starting this year the MHRA plans to upgrade the data presented in these reports. We shall see what that brings.

[Poor Man -]

Nice work Hype.

That explains why many have been pointing an arrow toward the end of March. Hopefully there are other meaningful drivers (e.g., combo trial partnership and uplist) in the timeline between now and then.

Summer does seems the most likely in terms of early approval scenarios, since questions will invariably come out of the March CHM Meeting.

[H2R]

Hi hyperopia,

Thank you so much for the scenarios.
What would you expect to be the first indication of the remaining timeline.

For example, if high priority is assumed, would you expect a PR after the first 80 days + a few days from NWBO or an information from MHRA to indicate an RFI or a non RFI, so say end of march?

Thanks again!

Best of luck to Patients, NWBO, and Longs!