Replies to post #776801 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

"If DCVax-L is approved after July 23, it benefits from this framework directly. If approved before, any later switch to Flaskworks would be considered a major variation, requiring extensive revalidation."

I thought flaskworks was allready approved and part of the submission.
I also thought variations had to be submitted during approval process.
Why would a better automated system delay approval of a treatment? Better systems are developed all the time and stand on their own for validation.

"What are the implications of SI 2025 No. 87?
The implications of SI 2025 No. 87, which takes effect at the UK’s MHRA on July 23, 2025, are quite significant—especially for cutting-edge therapies like DCVax-L from Northwest Biotherapeutics."


This is why I hate AI. What will tomorrow be like? Answer- tomorrow will have weather and last 24 hrs.

If approval happens this week or the next, I'll be happy as a clam. But I don't believe the delay of over 1 1/2 years was due to waiting for this new regulation. It seems like investors are trying to find a timeline on which to look forward to and are creating narratives to justify this timeline. JMO

[Investor082]

Such BS. Flaskworks will not be approved until 2027 at the earliest. That too if everything goes according to the plan. And you can’t expect that from NWBO team.

For now, the posturing and excuses from minions strongly indicates not to expect approval this year.

New all time lows coming!

[tucsonchas]

Terrific post, Follower. Keep it up!

[JTORENCE]

TheFollower So the question is - come July 23 MHRA approval will come with a touch of a button or will there be more delays associated with implementing the new regulations.