'Nigel has just started the first RCT of Oncosil treatment, and the German trial will be the second. And that's with very limited capital. No short cuts, the real work.
The previous mob had 10 years to do that. Yes, they got a CE mark, which was fine. But that's not enough for reimbursement and clinician adoption, you need RCTs.'
Tiny - you are spot on with the CE mark and RCT. People think the CE mark is some magic want. It's not, just shows that the manufacturing process is at a certifiable standard, have nothing to do with if the product does what is claimed.
The RCT is a worry. As you know from Sirtex days, these can take years to recruit and publish the data, and are very expensive to get to publication stage. Pharma is a lot quicker and less expensive, medical devices are a darned hard field to be playing in. Look at the LVAD (heart) companies that have gone bust over the last 20 years, including our own Ventracor in Sydney and World Heart in Utah which was around for well over 20 years and still could not get good trial data. Is anyone making serious money from LVADs these days?
Lastly, Nigel was in charge of EU sales and only stepped up to CEO when Gilman was pushed onto his sword SRX were in chaos and Nigel was a safe pair of hands.
Best.
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