RE: Morning9 Jun 2024 13:34
No changes can be made. If that was the case they would have notified and discuss with the regulator beforehand and also they would have to RNS it. That's just how it works.
One note that some here don't seem to take into account. It isn't just the 13 week scans that matrer. All subsequent scans matter. ORR is estimated at every scan and it's not like if we only had those 13 patients (for example) until the end of the trial the ORR would be 85% pepretually. At a subsequent scan, a patient that was previously a responder could have progressed, so the ORR would be lower at that later timepoint. Similarly, another patient that wasn't a responder previously, could then show a storng enough response so that ORR would be higher at that timepoint. So when we refer to updates, it isn't just for new patients, but also how the ones we already have previous data on are doing.