Replies to post #828539 on NorthWest Biotherapeutics Inc (NWBO)

[Flexroy]

My sentiments exactly!

[Doc logic]

meirluc,

So here is my question. Did the expert working group only point to a need for more leukapheresis capacity needed for CHM to consider or did they also indicate a need for more dedicated clean room space for increased artisan method manufacturing since the Class C buildout was put on hold and no update from Flaskworks development has been given but a contract manufacturer search has been? Kind of important things to be made aware of but because the application process is still progressing, we likely will not be made fully aware of what is taking place to address concerns that seem to be centered on potential to likely manufacturing capacity limitations with regard to anticipated initial demand. Best wishes.

[FrostyIsland3]

Meirluc, who are you quoting?

[learningcurve2020]

Come on stop with AI already! CTBVEAG is almost certainly questioning the validity of the trial not manufacturing capacity.

I just figured out why Danish built his own NWBO site with cookies, ads, and all the bells and whistles. It’s so AI can scan it like it’s a legitimate source.

[antihama]

AI's making sense. Starting its own dedicated leukapheresis clinic dovetails nicely w possible CTBVEAG Meeting manufacturing concerns.

The relation between the two dates you highlighted follows a standard, sequential regulatory process rather than a conflicting one: November 24, 2025 (CTBVEAG Meeting): As an Expert Advisory Group reporting directly to the Commission on Human Medicines (CHM), the CTBVEAG's role is to evaluate specific technical, biological, and clinical trial aspects of an application. They compile their expert input and raise "points for clarification". November 27–28, 2025 (CHM Review): The CHM is the senior overarching body. The timing of these meetings is intentionally linked. The CHM relies directly on the fresh briefing papers, conclusions, and specific points raised by the CTBVEAG just days prior to shape their broader assessment of the MAA. Rather than a rejection, questions raised at this stage of an advanced therapy review typically represent a "Day 180" style list of remaining questions. These frequently concern the scaling of personal cell-therapy manufacturing—such as the validation of NWBO's Sawston facility and automated cleanroom methodologies—which the applicant must satisfy before final authorization can be granted"