OK.
reading about FDA Breakthrough Device Exemption has been interesting.
I’m starting to wonder if comments here about pivotal trials might not have accounted for the radical nature of this status.
It’s possible that if FDA likes what OSL is showing, might it not need to undertake classical pivotal RCT trials.
It may allow it into the market with staged approval using post marketing surveillance.
Marketing approval in 18 months is not impossible.
Happy to be contradicted, but my research suggests it’s possible.
Ann: Oncosil breakthrough device receives CE Marking approval, page-165
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