NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

As MHRA has no overdue MAAs per their timeclock, and NWBO's is something like 370-420 calendar days (depending when the clock started) since verification, does that not imply a clock stop time in the range of 160-210 days?

no one is denying the delay compared to the average timeline.

If MHRA’s internal clock for accelerated review is 150–210 days max, but we’re at ~480 calendar days, then Clock stopS must have occurred, thats undeniable.
And by your estimate, If we subtract 150–210 working days from 370–420 calendar days, that implies NWBO’s application has been on “clock stop” for at least 160–210 calendar days and that’s exactly what happens during the first RFI (clock off request x2?) and or + follow-up questions where NWBO took their time to respond and that is where we are now.

This doesn’t mean there’s a problem clock stops are normal. But it does mean that NWBO has been in active dialogue with MHRA for far longer than a smooth, unproblematic MAA review. As I have said here before Les told us they are being "highly scrutinized". That raises the possibility that either the MHRA had complex issues to resolve, or NWBO had to fix or clarify something substantial.

So the MHRA is not delayed its NWBO being the snail turtle they have always been taking their clock off time as LONGGGGG as they feel needed to. And that fits very neatly with NWBO’s 10-K language: “continued engagement,” “ongoing documentation,” and no final timeline.

IMO