You obviously have absolutely no knowledge of the FDA approval process or CE requirements. FDA approval for the study has gone exactly as expected. Follow up clinical studies are a requirement of CE approval. CE approval would have been waiting for a well planned Clinical Study and the results of the "Hot" run to prove operator safety.
There is one strong positive point about the CE approval.
IT HASN'T BEEN REJECTED. The Notifying Body has had 10 months to reject the application. IT HASN'T BEEN REJECTED.
The approval process is still ongoing and should be approved in the near future now that the clinical study and calibration plus safety demonstrated.
Patients are definitely unwell. In fact they are going to die a very unpleasant death. To suitable Patients Oncosil will offer some pain relief and prolong their life, however short that may be. It will be the Patients choice to pay for treatment.
Your post doesn't add any value.
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