NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

dmb2

Re: Doc logic post# 706926

Sunday, July 21, 2024 7:39:11 PM

Post#
707465
of 707475
Doc logic, I think FDA has become more political in recent years, it once was the drug regulatory leader in the world regarding its processes and its scientific decision making. That appears to be changing and it has become more apparent that there is more than a noble agenda of protecting the public at play at FDA, sounds a bit like the USA financial markets. The UK has always been quite analytical in its approach and its processes. We always knew at site inspection time the FDA would require massive documents to review at the site while the UK inspectors would take more time to physically inspect the site, and more thoroughly review the physical processing areas and equipment.
The EU has always been a bit of a maze to work with due to the country differences which still exist, though approvals are now more streamlined due to the single process. There are still country level differences regarding labeling, transportation, distribution as well as quality issue resolution though the ICH process continues to reduce major regulatory differences.

All in all it is fair to say what NWBO has undertaken has been a significant set of accomplishments and their strategy will hopefully turn out to be valuable as well as telling regarding how the FDA has slipped. I would love to know more about their pivot to the UK, but that is probably never to be revealed completely.

I am hoping the PIM designation comes through with some prioritization for DCVax-L approval soon.

GLTA