Replies to post #664648 on NorthWest Biotherapeutics Inc (NWBO)

[Bright Boy]

I'm afraid the Flip has flipped!!!

Cheers,

BB

[sentiment_stocks]

Regarding the PIP and PRing milestones... the point of PRing that the setting up the PIP trial was completed (and we'd heard nary a word about a PIP prior to MHRA's acceptance of their proposed trial) was just that... the process, or milestone, was complete.

The company makes a point of not publicly updating us on milestone projects they are in the middle of.

They don't consider this "validation" a milestone, but rather bookkeeping.

[aperture007]

Flipp, I totally agree! Announcing the validation confirmation is the right thing to do for NWBO and its investors.

Please keep up with the great posting. You're an outstanding asset to this board.

[Margin Buu]

Flipper, WHY didn’t the company make any mention in any of their PRs about acceptance of the application where it would have been pertinent to tell shareholders as a group as opposed to some off handed comment that Dave Innes made to a shareholder? They laid out exactly what they planned to update shareholders on in their Oct 13th PR.

1. Delivery to the Publisher
2. Once MAA is submitted

And in subsequent PRs the company made no mention about acceptance of the application. Why wouldn’t they reiterate DI’s off hand comments if it was such an important step in the process? I can only conclude it is not.

Oct 13th PR for reference: “ The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.”

No ones hating on Dave or you for that matter. I’m just not holding my breath for the company to announce acceptance of the MAA. I think we can safely move on to waiting for approval.

[Springbok80]

Interpretation of Validation:

Validation vs. Assessment: MHRA clearly distinguishes between validation (confirming completeness) and assessment (evaluating scientific merit). Public announcements around validation could inadvertently misinterpret this preliminary step as a signal of imminent approval, potentially misleading stakeholders.
Focus on Public and Investor Protection: MHRA prioritizes safeguarding public trust and preventing potentially detrimental speculation. Early pronouncements about unassessed drugs could fuel unrealistic expectations and undermine the importance of a rigorous evaluation process.

Regulatory Precedent:

EU Marketing Authorisation Procedure: Though separate from the UK now, the previous centralized authorization process under the EU Medicines Agency (EMA) discouraged press releases on validation, encouraging communication only after positive scientific opinions were issued. This practice serves as a reference point for UK regulations.