Replies to post #805931 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Further artificial intelligence opinion.

The reason these two things feel confounded is that Linda Powers blended them on purpose. She described the RFI "Cycles" to explain away the two-year delay and lower retail expectations. But she then used the 28-Day Clean-Up timeline to set her January 31 construction start.
If they were still in a "Major Objection" RFI, she would not be breaking ground in 30 days. The only way she can commit to a physical construction start on January 31 is if the RFI phase is closed and they are currently in the final 28-day "Clean-Up" triggered by the November 28 CHM advice.
She used the 'RFI' language to hide the fact that she’s actually in the 'Clean-Up' phase. (Hypothetically)

[ATLnsider]

According to your AI analysis, I am correct and we agree on the following:

1. There are no remaining major objections or deficiencies. As a result, no 28-day CHM letter is required or needed.

2. This fact is further supported by the actions of Linda Powers moving forward with the construction of the simplified Class C suites at the Sawston facility.

3. “If the CHM provides a Positive Opinion with conditions for 28 day response, the MHRA doesn't issue a "CHM Letter" (which is reserved for objections). Instead, they move directly to the Grant Procedure”’.

Let me know if you disagree with any of these 3 points.

Also, please provide a non-AI / actual MHRA guidance link showing that if the CHM provides a positive opinion, they will give the Sponsor 28-days to meet the minor conditions.

I do agree that if the CHM committee provides a positive opinion, then the MHRA may issue a Grant (Approval) decision letter with minor conditions, but it does not come with a 28-day letter response requirement.

But, if you have a link to this requirement, please provide it.