NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

George is a really nice guy and answered all my questions truthfully. I suggest people reach out to him and get the facts, no the pure BS that gets spouted on this board from both bears and bulls

He absolutely is. I reached out to him through the proper channel and received permission to paraphrase the following clarification:

On the recent “labeling phase” discussion. There isn’t a separate labeling phase in the MHRA review. The product-label materials (SmPC, PIL and other packaging labels) are submitted with the MAA and are assessed alongside the clinical and scientific dossier. During review, regulators may send formal queries to align specific label statements with the supporting evidence, but this is part of the normal dossier review - not a distinct phase - and any label language must remain consistent with the submitted data.

Regarding the ongoing review, the company remains actively engaged with MHRA and responds to requests as efficiently as possible. Given that this is a first-in-class cell therapy, a careful and thorough review is to be expected. No timeline has been provided, and no additional process labels (e.g., “waiting for guidance” or “in labeling”) are being used by the company.

With that clarified, here is how the message-board statements line up with the company’s explanation:

Labeling
Treating “labeling phase” as a distinct stage is incorrect. Labels are already part of the filed MAA and are assessed alongside the dossier, so there is no separate phase to “be in” or to be “delayed.”

Attribution
The phrasing about a “labeling phase” is not company language. It should not be attributed to NWBO’s representatives.

Status/timing
The company has not given a timeline. Any specific time estimate on the board is speculation by posters, not an official update.

Bottom line
The message-board narrative does not match the company’s process clarification. Labels are reviewed as part of the MAA package; the review is active and careful; no timeline has been issued.

My words:

Considering you July 6th-7th. forwarded an email from awj23060 (now a deleted account on X, with the same postfix 23060 as fireman23060, account on Ihub last seen december 2022 a month before Smitty5150 account was created), regarding an MHRA correspondance, and stated

Does it mean they are currently under a RFI? Or does it mean some sort of rejection?

Knowing what we know today regarding MHRA conversations Lykiri and others had, it is enlightening to revisit what you stated and insinuated in the posts following your announcement of that MHRA conversation, correlating it with this company conversation. You seem to like to steer sentiment from conversations with MHRA and management towards something that can be branded as negatively, that retailers can then "build on", and then you can distance yourself afterwards saying

"... this is the exact reason why I refuse to share the "meat and potatoes" of what my conversation with GZ was about.", while having still shared a negative biased opinion of what was discussed, and obviously wasn't at all said. I prefer a conversation in writing, so there is nothing that can be misunderstood.

Anyway ... kudos. Nice little niche you seem to have gotten yourself, unless - of course - someone actually take you up on your word and do their homework by verifying the sources.

Oh ... and nice touch how you get to state, how bulls are wrong all the time 😅 The clientele here loves that!

The Bulls....Danish, Slave, Dstock and others are on the same side, and all have been wrong.

There is massive misinformation on both sides, some are so ridiculous I cant fathom how they come up with this stuff, its truly mind-boggling.

Yeah ... truly is mind-boggling ... and still you hold your own, as one of the great content creators in that regard. 🤔

"actively engaged "
LOL, I am actively engaged in the next Powerball drawing.
- SeekingAnyKindOfEnlightenment

Thank you for your always active engaging contributions to this board. What should we do without such knowledge?