NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Thank you for posting that.

If there was no 4th RFI (which would be a materail event that had to be disclosed in the last 10Q), then the only logical conclusion is this:
The MHRA does not consider the DCVax-L review to be in backlog because the extra time is not coming from MHRA at all. It is coming from clock-stops on the sponsor’s side, which only happen when the company is supplying additional CMC/manufacturing data.

And that leads to the obvious point: a manual GBM n/r dossier would never generate clock-stops long enough to push a validated ATMP review this far beyond the normal 210-day clock-on review window without the MHRA classifying it as backlog.

So if no 4th RFI exists, the only explanation that fits both the timing and the MHRA’s statement in Parliament (“not affected by any backlogs”) is that NWBO has provided major CMC updates almost certainly involving Flaskworks/Eden which stop the regulatory clock on their side, not on MHRA’s. This is reinforced by the basic reality that NWBO would be insane to invest $15M+ in a manual Grade C build-out with zero NICE viability, only to scrap it months later when Flaskworks is certified.

This is the only scenario in which:
* the calendar time becomes extreme,
* the MHRA does not count it as their delay,
* and the review is still officially “active” rather than “late.”

Everything else collapses under its own contradictions.