OSL oncosil medical ltd

Gladly Thymus, " Director for Strategy, Dr Roger Aston We’ve had...

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    Gladly Thymus,

    "
    Director for Strategy, Dr Roger Aston
    We’ve had verbal confirmation from a major regulatory authority that BrachySilTM is expected to be categorised as a “device” instead of a “drug”. Because the registration process is typically shorter than the regulatory process involving a pharmaceutical drug, we believe a shorter timeframe is feasible."

    http://www.sec.gov/Archives/edgar/data/1314102/000114420405005323/ex99.htm

    An IDE was submitted with the FDA. Roger was as bold as to inform the markets that the application would succeed... alas 10+ years later, the company still hasn't come to terms with rejection.
 
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