NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

When I spoke to the company, they told me that they have learned that the MHRA can issue as many RFI's as they want

that is common MHRA regulation knowledge. So one can not conclude they meant to tell you to be aware that they are having multiple RFIs. And again a second RFI is a material event that they should have disclosed in the last 10K. This does not sound like they have been slapped with a second RFI

The Company continued working with teams of specialized consultants on the MAA process, including onsite inspections in the U.K. and U.S., and ongoing production of documents and information before, during and after the inspections. The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible. As previously reported, the Company plans to announce the results when the MHRA review and decision-making is finished and does not plan to provide interim updates.

- suggests active document generation and submission beyond just a one-time RFI — but it doesn’t confirm a formal second RFI.
- implies real-time regulatory engagement, likely responding to questions, clarifications, or follow-ups.
- The tone would not make sense if they were waiting passively for MHRA to issue a new RFI. It implies they believe they’re progressing, not delayed.