Replies to post #776279 on NorthWest Biotherapeutics Inc (NWBO)

[jesster64]

OK, this does not make sense. You're saying the MHRA is delaying authorization of dc-vax until eden system is approved if I read this correctly. One reason is they don't want the "headache" on having to approve it again later as a "major variation". Which I just can't believe. The MHRA, which prides itself on time of application to time of approval, is purposefully delaying approval because a small biotech company wants them to wait for a more advanced manufacturing capability?
If that were the case, wouldn't the MHRA reject the application prior to waiting 1 1/2 years , citing the reason being not enough manufacturing capability and ask NWBO to resubmit after eden was approved?
I don't believe the MHRA would delay. Its no skin off their nose approving again after major variation. Thats their job.
Production of flaskworks began in Feb 2024.
I'm sure eden works with a number of other BP agents as well as Merck.

I may be misinterpreting what was posted, as i said many times, i am not an expert, just using common sense as my guide

[attilathehunt]

Approval = All cancers and EDEN?!?!?!?

That would explain the long wait.

[seekinganswers]

"Form 10K Page 26, Flaskworks System." ....the Company has been holding off on proceeding with the fabrication....

Maybe read the 10k sometime?

[bas2020]

I don't believe the MHRA delay is waiting for Eden. LP said previously that they will start with artisan (Advent) for initial production... and now they have IFR funding to accommodate and cover the initial lower-volume production and treatments. The new regulation #87, accommodating modular manufacturing, will enable Flaskworks introduction, which will also likely line up with NICE approval timing.

[joeycav11]

Makes sense that the long wait was for Eden Flaskworks approval and we know all cancers are approved for payment via specials program.
You get one chance to make the huge announcement and Britain plans on capitalizing on the headline and selling treatments to paying customers all over the world.
Thats just one benefit of being world leader in being first mover in regulatory approval of a new cutting edge stem cell therapy

[joeycav11]

Makes sense that the long wait was for Eden Flaskworks approval and we know all cancers are approved for payment via specials program.
You get one chance to make the huge announcement and Britain plans on capitalizing on the headline and selling treatments to paying customers all over the world.
Thats just one benefit of being world leader in being first mover in regulatory approval of a new cutting edge stem cell therapy