NorthWest Biotherapeutics Inc (NWBO)

[Horseb4CarT]

The PIP is the trials plan, not the completed pediatric trials themselves, and the PR is stating the PIP has been approved and the trials can be done post MAA application and marketing approval for the adults!

So with this requirement checked off, we await final Sawston DCVax-L manufacturing approval and marketing approval itself in rapid succession!

The subtext messaging is also important, that the use of external placebo controls is approved as part of the PIP and thus reinforces that the phase 3 use of external controls is not an issue. This is consistent with the UK accepting the SAP with OS endpoints and external controls!!!

Imo, all signs are a go for UK approval!