Replies to post #702627 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Do you know why the MHRA has not communicated with NWBO AFTER 157 days from CLOCKSTART on:

First, you do not know when clock started. Read that email reply from MHRA a bit closer. It just said "based on the PR...". Many have gone wrong interpreting LP PRs.

1. Whether this is a 150 day process?

So MHRA has not yet said the submission was of high quality standards to justify the 150 day pathway. OK.

2. Whether there will be an RFI (which would by now be 77 days late)?

How do you know RFI's have not been issued?

3. Whether there will be any inspections beyond the GMP and other inspections already conducted on the facility and process?

Of course there will be inspections. That is known.

[barnstormer]

Flounder - great descriptive term - to experience great difficulties or be completely unable to decide what to do or say next: Wouldn't be the first time we've found ourselves in the position over the years. Maybe there should be a company team or t-shirt with the logo NWBO Flounders (or maybe should read as Flounderers?) Hopefully to be soon replaced with a better term.

[Investor082]

They are not ready for commercialization. If the approval was coming in a couple of months they would have been hiring.

From a manufacturing perspective they are ready, but not from the perspective of all other critical business functions. Perhaps they only expect to clock $5-10M in annual revenue in 2025 and therefore will add a handful of folks to support that as approvals come?

And how can they not have the pricing model all figured by now almost 4 years since data lock? Typical NWBO management with no sense of urgency. Again, don't expect reimbursement approval for another year or more.

In fact, some of the gofundme UK specials patients over the last 6 odd months have been reporting that NICE/NHS support is 18-24 months away and that makes sense given what we know now and NWBO’s posture. Reimbursements will likely come around mid next year at the earliest. But more likely towards the end of next year given the history of this management.