I agree with you.
I find it hard to imagine an intervention like this not being CE approved, but then weirder things have happened.
I also find it frustrating that the CE process is completely opaque, unlike the FDA which (although tougher) seems more transparent. It's almost impossible for an outsider to get an idea of what is going on: standards; meeting dates; past approvals. This makes investing for that outcome v difficult.
I can barely find a single reference to this Clinical Oversight Committee in the public domain: it's roles and functions, much less who's on it, when it meets etc.
The fallback question then becomes, what is this technology worth to a partner/acquirer?
Ann: Positive Overall Survival data released at ASCO 2019 Chicago, page-20
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