Replies to post #774304 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

When NorthwestBio submitted the Marketing Authorization Application for DCVax-L to the MHRA in December 2022, they weren’t just asking for approval of a novel drug. They were asking the UK regulator to assess and potentially authorize an entirely new category of medicine.

MHRA has already approved an autologous DC vaccine that uses the patient's own cells.,

They have approved other personalized cell therapies.

The idea DC-L is so novel is just a case of disconnect from the real world often exhibited by "certain longs".

[mxp1]

Slave 1. What is your background? I love your posts!

[barnstormer]

Slave, all true. I can understand the scientific caution as well as possible political concerns that contributed to the delays. Now, if I may be cynical for a moment, I would speculate that if instead of a small American biotech not well funded or politically connected, the MAA had been submitted by a larger company, say GSK, the scientists and politicians would have found a way to deal with the submission more expeditiously.

[Doc logic]

Slave1,

The sod busting is nearly over and the international runway built for Direct. The greatest fear of big pharma is that Direct gets turned loose without them. For at least 13 years they had their chance and now retail and Linda are in control. Best wishes.

[sentiment_stocks]

Thank you for all of your very informative, helpful posts. I just want to make one little correction to the post I’m responding to, and that is that the MAA was submitted to MHRA in December 2023, not 2022. You likely knew that and probably just mistyped the 2 instead of the 3. I just want to make sure no one else thinks MHRA is taking a full year longer than they already have taken to arrive at their decision. :)

https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/