'I think they will get CE, just a matter of patience waiting.'
Agreed. It will probably come.
I don't think the private CE certifiers actually ever say no. Our friend with the newer y-90 went through a number of Notified Bodies attempting to get the CE mark. None refused, but they just keep the client on until the client conforms or tries their luck elsewhere. And he had a head start as he already had trial data for over 74 pts, in fact the very data that the FDA used to grant a PMA back in 2002 to his original company
As BSI is I believe the only major Notified Body of any worth in relation to radioactive implantable devices that means, as in the above case, getting involved with bodies that are not too experienced and tend to work for the fringe EU countries, Gets very messy.
BSI would be the 'gold standard' for said CE mark, and as such tend to have high standards. But OSL management would have known this 2 years ago.
It will probably come, but I feel sorry for the punters that piled into OSL as well above 20c thinking this would be a walk in the park.
And for those hanging on in the hope that a CE will bring huge returns, them I'm afraid that there is a very long path to be trodden, probably some years, before the revenue exceeds the costs. Trials cost money - 300 pts is probably in excess of $15/20m for implantable radioactive devices. Probably the best outcome is to get the data for the small sample as per the FDA, and then sell the company to someone who has a ready built sales and distribution channel into the US markets and is fully conversant with implantable radioactive devices.
There are one or two around
OSL Price at posting:
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