NorthWest Biotherapeutics Inc (NWBO)

[Baxers]

SemperFi. At this point I honestly dont know tbh. We once again find ourselves stretching beyond any equivalent precedent and beyond the supposed statutory clock limit for this part of the assessment, but then if the rest of this assessment is anything to go by, this is nothing new for us. A few things I am trying to keep in perspective to stay sane:

- If we are to believe what GZ mentioned to someone here, then we are genuinely at the label negotiation phase and CMC must have been approved by the November CHM. I therefore doubt that we are awaiting a further CHM meeting at this point.

- For this 2nd CHM > Announcement to go longer than Kisunla and Leqembi (180 and 182 days respectively) that I have previously received highly complicated restricted population approvals, could of course be possible, but I think there would need to be some specific reason in particular. If we have no approval by 29th May then we would be exceeding every single other application of any time and any state of approval for the same approval pathway...

- For a potential specific reason, I was recently told by someone (who had this confirmed directly from the MHRA) contrary to what my own research had led me to believe that Variation applications ARE in fact allowed while an assessment is still in process. This is now purely conjecture, but with this given, it opens up the possibility that either FW could have been added to the assessment or (probably slightly more likely) RWD/ Specials/ Phase 1/2 data has been added to the assessment to try and get a conditional approval for DCVax as a monotherapy/ DCVax + Poly ICLC/ DCVax for Grade 3 Gliomas. I'm not giving any weight to these ideas, but it is more a hope that this is the cause for this phase taking so damn long.

- I do not think that the company are dragging their feet in order to avoid having to make the 10mil payment to Cognate. At this juncture, the only means they would have to do that would be to slow-walk MHRA requests on purpose to stall the final announcement. Given how much is pivotal on the MA, I therefore find avoiding this 10mil payment hard to believe.

GLTA