The big difference between early Oncosil and early Sirtex is that Sirtex's first serious clinical study although also very small, was a randomised study. Daniel Kenny (previous Oncosil CEO) made a terrible mistake by not making Panco a small randomised trial. Poor Board and management decision and wasted funds. An RCT would have sailed past CE mark, and made reimbursement easier.
The other difference is FDA accepted that Sirtex RCT for humanitarian use, I think. They started selling into the USA early then off label use too.
Oncosil, even when Europe comes good, will never have the funds to undertake formal FDA type RCTs for an NDA. So, a partner will be needed.
Maybe Sirtex?
Ann: Bupa UK Approves Reimbursement for OncoSil in the UK, page-33
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