NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Doc, your guess is in the ball park. I’m not as familiar with the MHRA, but the FDA lists their submission times here:

Submission Times

The following transaction times are generated quarterly based on PDUFA submissions. Your company submission times may be above or below these transaction averages, sometimes by a significant amount. There are a number of factors that affect submission upload and processing times. Below are some of these factors:

Internet connection bandwidth: The bandwidth your Internet Service Provider (ISP) provides to your company

Internet connection bandwidth consumption: The amount of available bandwidth is currently in use by the company. Upload speed can be determined by going to: http://beta.speedtest.netExternal Link Disclaimer

Geographic proximity to FDA (Washington DC): The farther your location from FDA, the more network hops are required for your connection to reach FDA. The more hops your connection takes to get to FDA, the longer your submission will take to get to FDA
Data compression ratio (for multi-file submissions) and submission composition:  The number of files and folders/directories and the type of data you are sending will affect the speed at which the submission makes it to FDA

End client/user infrastructure: Capacity of end user's machine (processor and memory), network storage performance, and shared vs dedicated machine might also affect the speed of signing the submission and upload

Uploading a submission during  infrastructure maintenance (end user's and/or FDA)
Submission traffic during the specific period:  Multiple, very large submissions (e.g., over 10 GB) being received concurrently, then the ACK times will vary.

https://www.fda.gov/industry/about-esg/submission-times

FDA Electronic Submissions Gateway
https://www.fda.gov/industry/electronic-submissions-gateway

About ESG

What is ESG?
The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is a highly scalable, easily available, high performance and secure exchange point for FDA and its partners to transact a variety of documents and submissions over industry-standard protocols. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. The FDA ESG enables the FDA to process regulatory information automatically, functioning as a single point of entry for receiving and processing all electronic submissions in a highly secure environment.  The FDA ESG complies with secure Hypertext Transfer Protocol (HTTP) messaging standards and uses digital certificates for secure communication. The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing and notification (to a receiving Center or Office) of the delivery of an electronic submission.
FDA ESG provides two methods, WebTrader (WT) and AS2, for making submissions to FDA.  FDA ESG has been in production since 2006 and is used by 100s of users to send 1,000s of submissions every day.

* WT: A web portal designed for low volume submitters. WT allows users to login, digitally sign and submissions, and view responses through a simple web interface.
* AS2: A system-to-system connection to exchange submissions with FDA. AS2 requires a Gateway software implementation on submitters end.

Where do Submissions Go?
The FDA ESG is the central receipt point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit, or "highway", along which submissions travel to reach their final destination. The FDA ESG does not open or review submissions, but automatically routes them to the proper FDA Center or Office.  Industry Partners can send a receive documents from the Gateway via a web interface or server to server communications.

https://www.fda.gov/industry/electronic-submissions-gateway/about-esg