NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

Assuming this is not bogus, it doesn't tell us anything about how the MHRA is leaning.

Someone on this board, FeMike perhaps, had said that they were told by NW that they were getting multiple RFIs. This application is over a million pages, and it's quite novel in being a biologic, not a drug, and the SAP relies on ECA for the placebo arm. It would not be a big stretch to think that MHRA continues to find points they need to have clarified or need additional info on. Maybe nitpicking and maybe more substantial.

Nor would it be a huge surprise if MHRA wanted to delay responding until they get their full ECA guidance done before ruling on this, but they don't want to carry the MAA on their books as overdue, i.e., delayed on their responsibility. In that case, they could use the RFI process just to keep kicking the ball back to NW so that MHRA's clock is not running while they wait. IMO, that would not be an unusual bureaucratic tactic in such circumstances.