NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I have been thinking more about Les’ 27 modules number. I do agree that for most countries, especially in Europe and Japan, they have adopted the 5 core modules that make up the Common Technical Document (CTD). But, each country reserves the right to ask for more modules than the 5 core modules.

However, 27 is not evenly divisible by 5, so that tells me that every regulatory authority (RA) is not requiring only 5 modules. At least 1 RA is requiring a different number of modules than 5.

I went back and reviewed the answers I was provided from ChatGPT, and I also reviewed the message posts and links from Lykiri and hyperopia again.

The ChatGPT answers I was provided shows 7 core modules for the FDA (see below), and 2 optional modules (modules 8 & 9) would be required for “certain specific submissions, such as for new indications or post-approval changes”.

As a result of these reviews, I have updated my number of required modules table below. I changed the number of FDA modules to 7, and changed all the other RAs to 5 to comply with the CTD.

My analysis suggests that there will be 1 additional RA to account for a total of 27 modules. My guess for the unknown RA would be a Project Orbis county, such as: Australia, Brazil, Israel or Switzerland.

These are only guesses, and I welcome other guesses: