I guess though the question remains whether they can actually achieve the CE mark based on what has been submitted or they need to gather better quality evidence from a new well designed trial.
If there is a problem with the scientific evidence so far submitted which effectively makes its efficacy or safety open to doubt, then no amount of post hoc explanation can change that.
New understanding gained from previous a study can change leading to a better designed trial which can then offer more conclusive scientific proof. But given that the treatment uses radiation which has the potential to cause significant harm, the evidence of efficacy and degree of certainty is paramount.
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