That's why I said that NICE needs to get an evidence submission, at the same time as MHRA get the MAA. So that the processes can be parallel pursued.
IIRC, one of the Car-T's got a favourable NICE recommendation within a week of garnering an approval (from the EMA I think).
The other one got a no-go (at least initially).
And you are correct about Sawston. I'm fully aware of that. It needs kitting out to at least their initial intended capacity. Then go through rigorous inspection leading to the granting of a manufacturer's licence.
Plus the Advent team need to physically relocate from London.
Though I suspect there is quite a bit of toing and froing going on already.
I've never been particularly concerned about a NICE price ceiling. There are grounds to think a price above the normal QALY ceiling could be applied in any case. There may well be a case for the 'end of life' supplement, which I believe is up to 1.7 times the normal QALY ceiling, given the life expectancy that comes with a GBM diagnosis.
And it probably also classifies as a rare condition, and one without an effective treatment.
It would be an absolute drop in the ocean compared to Covid expenditure....
I imagine some sort of results-based pricing might come into the equation, perhaps with differential pricing for meth and unmeth.
Plus I think that NWBO would settle for a margin somewhat smaller than Merck gets for Keytruda! Though obviously they would want enough of a margin that would enable them to get on with some R+D, and get Direct off the backburner.
But first step first!