Ultimately it comes down to establishing proof that the treatment "works" and that is a long way off both in time and money.
I recall someone saying on YMYC... and happy to be corrected if I am wrong, about the long road in terms of time between Sirtex obtaining their CE mark and when they started turning a profit...
While reminiscing ... It was 30 years ago that I was working as a registrar at the hospital at which Bruce Gray developed Sirtex spheres... and it wasnt all smooth sailing ! These things take time and money.
For those with a legal background, Sirtex was a landmark case...
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