NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

ATLnsider, that’s an interesting theory on the number of modules required for a BLA/MAA. Maybe you saw my reply to the question senti asked about the odd number of modules Les mentioned here. While there are exceptions, generally for a marketing authorization application like the one Northwest Bios is likely submitting, there are 5 modules, which are standard and harmonized for most of the wold, and submitted in what’s known as an electronic Common Technical Document (eCTD) format. Modules 2-5 are exactly the same for all regions, and module 1 is region specific. This harmonization is how regulators around the world in consortiums like Project Orbis, are able to collaborate.

As I said in my reply to senti, it only makes sense to me if Les is counting sub-modules. (and that may be why you say there are 9 for the BLA?) I didn’t spell all this out in my reply to senti, but this is my best guess (see CTD Triangle below):
If you were to add module 1, and the 5 sub-modules of module 2, and modules 3-5, they total 9. So possibly, Les was saying that they are now preparing to file applications in 3 countries, which would add up to the 27 modules. And he did specifically mention 3 places: the UK, Canada, and Germany (EMA) . . . which all potentially could be handled now from Sawston.

Perhaps they plan to file next in the US, when commercial manufacturing/tech transfer (or partner) is established there. (maybe after approval in the UK) Comparability will need to be established in any new manufacturing facility, for the semi-automated commercial manufacturing process that Advent developed at Sawston. This should be relatively quick though, (a few months) since the change protocol from manual to semi-automated, has already been established, and it’s automated procedures.

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