NorthWest Biotherapeutics Inc (NWBO)

[HappyLibrarian]

No one has a problem with an extra one or two months if that all it really is. With NWBO a process that should take weeks (according to the management, not us) can turn into over a year.

At this point MHRA either supports DCVax-L or they don’t. They know the cost in lives of every month this treatment is unavailable and DCVax-L’s Phase 3 trial was supposedly an NHS priority and the product is being homegrown in the UK. If they are looking for an excuse to impose a delay then as bureaucrats they can always find it and no amount of delay will buy immunity from that. By contrast they are looking for a reason to make approval happen then as with the COVID-19 vaccines, they can do it and adding 1 or 2 months of NWBO-style OCD tweaking will not matter.

Maybe the dynamic is different with the FDA