Are we in another “fast track” scenario? But credit where it’s due, well done to OSL. Now the market looks forward to seeing and understanding the PMA trial, design, comparator arms, size, cost and timelines. They’ve been talking about pivotal randomised trial since 2014....
and CE remains in final phase still. Phew.
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oncosil medical ltd
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Ann: FDA Grants Breakthrough Device Designation, page-10
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