NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

FeMike,

There’s no contradiction, you’re just comparing a policy detail with a strategic reality.

NICE officially allows companies to submit their evidence file with a draft SmPC. That’s black and white in their documentation. They don’t require MHRA to finalize it first.

But in practice, most sponsors wait until MHRA labeling is basically settled before submitting to NICE. Why? Because the SmPC defines the population, indication, dosing, safety profile, everything NICE uses in its cost-effectiveness model. Submitting a draft that’s out of sync with MHRA would be pointless and probably get sent back.

So one quote is about what NICE permits, the other is about what companies actually do when they’re being smart.

Hope that clears it up.