Replies to post #336251 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

How did UK and Germany allow that change? Are they not regulators??

They are the regulators for insuring the trial is safe and ethical. For Germany, they are not the RA who would approve, that would be the EMA.

For the UK, the MHRA is the same body that will approve (assuming no last second BREXIT extension), but just like the FDA approval to run a trial does not mean they will accept the endpoint for approval.

The vast majority of trials have endpoints that are not designed for approval. And a fair number of P3s are not designed for approval on their own. But the RAs allow them them.