NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

The EMA was not even a party to those actions.

Well, if they received a draft SAP, and gave comment that wasn't a no no, then they were a party. They might have even had active input as to what endpoints they deemed appropriate given all the circumstances.

If NWBO decided unilaterally to change their endpoints without consultation with regulators, then they would probably have changed the UK and the European listings, (and maybe the US listing) at one and the same time. Which they didn't. I imagine they did it, in each case, after receiving regulator opinion (and they got the UK opinion first).

So, imo, it is more likely than not, that the EMA were a party, did not object, and may have actually gave opinion and/or recommendation, that led to the adoption of the new endpoints.

That does beg the question as to why the US trial listing did not change. And maybe the FDA gave a different opinion, which did not allow for the adoption of the new endpoints.
Not the end of the world. It justs makes me think that things will move more smoothly and quickly in the UK and Europe.

Yes, this involves a degree of conjecture.
But there is nothing wrong with applying reasonable conjecture to one's own analysis.