NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

I found it very interesting that, according to their latest quarterly, NWBO is now working with experts from the US, as well as the UK, to prepare for inspections related to marketing approval. I can't help but think they are now looking ahead to submitting an application to the FDA. This is the first time management has included the reference to working with former US inspectors to prepare for regulatory approval. While I think we all assume this section of the 10K is referring to the current MAA in front of MHRA, frankly, we wouldn't need US former inspectors to prepare us for UK approval, would we? I have to think this is NWBO's first nod to us that they are preparing for regulatory submission to the FDA.
Any thoughts, longs?

May 10, 2024, MD&A section, Pg 23:

Preparations for Regulatory Inspections. As anticipated in the Company’s prior reports, preparations for regulatory inspections associated with the MAA have continued to be a major focus of the Company’s activities this year to date. The Company has continued working intensively with teams of expert consultants in both the U.S. and U.K. on these preparations, and has also arranged for further mock inspections by specialists who were formerly inspectors for regulatory agencies. It is anticipated that teams of multiple inspectors for extended periods will conduct comprehensive inspections of all the key parties involved conducting in the Phase 3 trial and of all documentation and records. The Company does not know when MAA - related inspections may take place.

By comparison, this is the Annual 10K, March 5, 2024 p. 25

Activities associated with the MAA. In parallel with the drafting of the MAA itself, in 2023 we undertook a large-scale program of preparations for inspections. The regulatory authorities will conduct comprehensive inspections of the CRO, the TMF, the database provider, the sponsor, key trial site hospitals, the contract manufacturer and others. The Company worked throughout most of 2023 with large teams of consultants on preparations for inspection readiness of all parties and the TMF. Multiple mock inspections were arranged and were conducted by former regulatory agency inspectors in Q4. Further inspection readiness preparations are expected to continue to be a major focus of the Company and the large teams of consultants in the first half of 2024.