Replies to post #611825 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

How come the slightly more “connected” people are reverting to questions only lately. It’s like cognitive therapy on steroids.

[hyperopia]

senti, I recall that conversation, but I don’t know what Les was talking about when he said 27 modules. Now, if the number was 20 or 25, then it would make sense that they are applying to 4 or 5 countries, but 27 is an odd number. Your response to me, when I pointed out that there are only 5 modules, (and not 29) was that perhaps he meant sub-modules, which made some sense.

I also don't think the number of modules would be any less, based on any “new pathways” in any particular country. The regulatory requirements for approval shouldn't really be any less rigorous, even if the regulatory process is accelerated.

And yes, it does sound to me as though the MHRA may create a new, accelerated pathway for cancer vaccines, perhaps from development through approval.

The Common Technical Document
The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.

The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.
https://www.ich.org/page/ctd

CTD Triangle
https://admin.ich.org/sites/default/files/2021-02/CTD_triangle_color_Proofread.pdf