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.
CE Mark and commercial approval is about favourable benefit vs...
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