gekkowolf: I don’t make the regulatory rules and nor do you. Why did Osl announce a ? 300 patient RCT for the US years ago if it wasn’t necessary?
as this is too boring a discussion , I’d suggest as Osl has hired some good new people like CMO perhaps you contact them directly to find out whether or not they need RCT for US, what are their plans for RCT etc etc. and then you can debate with and argue with them as you clearly believe you know all about device regulations and how clinical trials work.
gekkowolf: I don’t make the regulatory rules and nor do you. Why...
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