Yes, I can understand your view. Traditionally the CE mark is somewhat easier to obtain than FDA approval, so it does not surprise me that FDA would reject something with a CE mark.
I'm very close to someone who fronted the FDA and obtained the PMA for a similar product, without too much trouble. And with such an aggressive cancer with poor prognostics, the FDA would very likely issue an IDE without too much trouble, IMO.
Due to the almost obscene medical reimbursement in the US, it really is the place to be with this sort of treatment. The EU is bogged down with national health systems who are always strapped for cash.
Anyway, I wish holders well and I'm sure the CE mark will be forthcoming.
In their PR of March 2014 they said
'The Company also advises that it is finalising preparations for its Investigational Device Exemption (IDE) submission for OncoSil™ with the US Food and Drug Administration (FDA). The submission of an IDE is a key step in the regulatory pathway for OncoSil™.'
Did they go for the IDE in the end?
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