Replies to post #619050 on NorthWest Biotherapeutics Inc (NWBO)

[MasterKit]

They mentioned it I think...

Since there are still patients living, the master file continues to be updated.

[learningcurve2020]

At some point they'll likely tell us that they're not going ahead with the application at this time until they run a confirmatory trial with poly. But they need to get everything in order first.

[CrashOverride]

Given it seems the NICE appraisal has began then this CRO work likely are being done for their QALY analysis.

[biosectinvestor]

The 10Q is a historical document reflecting what has been happening and some processes are an ongoing process, not something that is just one and done. The 2022 ASM happened 12/30/22, so basically they were describing what they were working on. Let's not suggest that simply drafting the "master file" has been going on for more than a year, which may or may not be the case, but again, the 10Q is a historical document and counsel and the company add important details over time. The sentence is incomplete if you look at it that way, as they go on to explain that they need all of their sites to be and remain inspection-ready for regulators as part of the approval process. They just updated the 10Q to reflect all of this work. It doesn't mean it is just happening or only happening now or isn't in a state of ready completion with ongoing maintenance. What that says is they are preparing to be inspection-ready for regulators as a part of that process and continue to maintain their records and files that are a part of that process, noting by the way that they are actually operating a factory now, so that has to be an ongoing process. This process will likely continue until they are actually inspected for marketing approval. It's an ongoing obligation.