Replies to post #789233 on NorthWest Biotherapeutics Inc (NWBO)

[AllSheWrote]

Yeah, I have some thoughts. It's not getting approved. There wasn't a third RFI, or a second RFI. The decision is not back in MHRA's hands because MHRA has no response to consider. NWBIO cannot respond to the first RFI, which asked them to provide patient-level data from the ECAs. All my opinion of course, but it really is that simple. You know it, too. Why would you deny that this is obviously the most likely scenario?

[Chiugray]

Sentiment, Your timeline is based on the MHRA’s official guidance:
- given where we are today
- procedurally it makes sense
- so a latest Nov 2, 2025 approval date also makes sense.

I'm looking at it differently but timing is in the same ballpark:
- I am thinking the gatekeeper is a review at the October 13-16 CHM meeting, then approval is 1 week later, late-October
- (slight chance, if reviewed at Sep 15-18 CHM meeting, then could be at the end of this month).

I am putting a high weight on these critical events:
- the new UK SI 2025 No. 87 on July 23, 2025
(speculation: NWBO amended MAA to include Flaskworks/Eden validation data)

- the acquisition of Advent BioServices on Aug 27, 2025
(interpretation: NWBO received internal signals for upcoming approval of Eden, ie start preparing for commercialization)

[RobotDroid]

Pure fictional hopium. Your dates are severely flawed.

[Doc logic]

sentiment_stocks,

This looks good but there is also the possibility for clock off time for expert opinion commentary allowed for in the guidance that MHRA can utilize and which can add in what seems to be an indeterminate amount of time. There seems to be an absolute time limit in the regs that you highlighted but this other avenue creates the kind of uncertainty that keeps investors and others guessing and I believe this is MHRA’s way of creating built in flexibility during review of novel situations. I had hoped for last September to be the announcement for artisan but lots has happened since then that suggests the bigger boat just keeps getting added on to in preparation for what the “experts” see is coming. Best wishes.

[hyperopia]

Hi senti, when the National assessment procedure for medicines was updated by the MHR in May, I did the same calculations, and came up with something similar. I would note that there is language in there that allows for extensions, so an exact end date can be flexible.

In exceptional cases, we may agree to extend the clock-stop period beyond 6 months.

In exceptional cases, we may agree to extend the clock-stop period beyond 3 months.

I remember posting a long while back discussing commercial pricing for DCVax, and I said that it wouldn’t surprise me if Northwest Bio acquired Advent and brought manufacturing in-house to keep the price as low as possible. I thought that this would only occur when they were actually ready to begin commercial manufacturing. The language in the Advent acquisition announcement said, “the transaction is expected to close as soon as certain legal conditions are fulfilled” which I thought might take a couple/few months. When I read the Advent acquisition announcement, I thought it probable that the approval decision was on the horizon.