The requirement for human clinical data to support CE certification has undoubtedly been known since January 2016 latest and most likely October 2015. Why only disclose now?
The IDE study can not start until IRB approval is achieved. This must be registered on clinicaltrials.gov. A complete list of all approved sites is required to be disclosed on this FDA clinical trial register. I suggest site approval will be equally as difficult as 20 patient enrolment.
If the Oncosil story was to become a movie it would have to be The Usual Suspects starring Daniel Kenny as Keyser Söze.
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