NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

"-They have added participating sites in Canada, UK, and Germany...and from the 10K the reasons for adding sites when the trial is almost enrolled is essentially to facilitate immediate market penetration in those countries...they have orphan drug designation and HE and PIM approval."

Canada is physically associated with the US, but in more ways, associated with Europe, specifically the UK and France, as you know.

The activity in Canada is great... but I don't know whether Canadian marketing approval hinges on FDA approval, or not.

Also not sure if the EMA and the FDA can end up with different decisions, given that it is a joint trial. This is a fundamental question. My excuse for not knowing... I guess I missed about 100K posts over the last year?

I do remember that the EMA usually takes longer than the FDA... which implies different decisions, but again, my understanding is that this is a joint trial, so not sure if that changes the rules.