NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Under Orbis MHRA can refer our application to all other regulatory authorities (RAs) without need for NWBO to submit separate applications to other RAs.

No, they cannot.

ORBIS requires an FDA submission and the review runs exact;y as it would w/o ORBIS. What ORBIS allows is for other RA,s to partake in the review and/or to use the review results to assist in their decisions.

As far as the rest of your post, running a P3 trial that failed badly between the arms as designed and trying to use post hoc ECAs (with non patient level data and unmatched trials) does not prove effectiveness.