One would wonder- maybe someone more familiar with the process could answer- are there significant differences between the submission to the FDA vs MHRA? I mean, the trial data doesn’t change. Make two copies and send to both? Or else count on Orbis participation?
One thing that I don’t understand about those comments about scanning thousand of pages of patient data . Data lock had occurred a while ago . Why would they have not scanned all that into digital files by now and wait till September
I also think that UK will act as quickly as they possibly can to approve and rest of Europe will follow. US could be prompted by their speed to approve sooner rather than later. IMO
Were not some board members posting that under an ORBIS submission, there could be a coordinated approval by the cooperating regulators?