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Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-33

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    An EFS - Early Feasibility Study - would be a small number:
    So sayeth the FDA

    A Pivotal study for a Medical Device would be analogous to a Phase-3 drug trial. Just what size patient cohort would be required I couldn't say.
    My mug's eye view would be that 500 would be the low end of a Pivotal Study.

    Informed opinions about plausible sequences to commercialsation welcomed.

    P
 
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