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exwannabe

03/11/26 3:02 PM

#817490 RE: skitahoe #817485

If they had chosen the FDA first, I don't believe that even now they could have submitted as they don't yet have an acceptable commercial production capability.


They had commercial scale manufacturing in the US in 2016 (per LP). But they sold that away.

Today, you are correct, They cannot use Sawston for the US (per LP in the 2016 10K). And the Pit facility is years away.

But why would anybody in this game care about the US market when they can flee to the UK market where NICE pays nothing because they are broke?
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RRP60

03/11/26 3:19 PM

#817495 RE: skitahoe #817485

I respect what you write but this may not be true though. I remember seeing a few companies, who had overseas manufacturing units. FDA inspect them as a part of the application process. 
Bullish
Bullish