CE Mark and commercial approval is about favourable benefit vs risk. I believe the 20 patients is needed by the FDA but the European regulators need to show that there is no radiation leakage/safety issues that outway the benefits eg. tumour shrinkage, pain reduction, patients living longer than chemotherapy alone, quality of life etc. Scans on 4 and 8 weeks for a bulk of patients should be enough for the CE Mark for commercial approval.
Should be an amazing 2018 and particularly for the life improvements of the patients.
OSL / SRX, page-6
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