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Ann: PolyNovo Concludes Recruitment for VAC Trial, page-6

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  1. 5,270 Posts.
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    re: Ann: PolyNovo Concludes Recruitment for V... Re recruitment:

    The last statement on the subject was in the AGM Presentation: "15 patients enrolled: 10 completed treatment, 2 withdrawn ( one in each group), 3 currently in treatment."

    So, at that time there remained seven patients to be recruited to complete the 20 patients required for the study. Those patients have apparently now been enrolled.

    Moosey, don't worry about funds; that's well under control for the coming full year at least.

    gmutton, I'd like to see that 510k application lodged by the START of Q3, at the latest. As of the AGM presentation the statement was made that the 510k application did not need to be supported by clinical data. OK, but I think it is wise that we do so in any case. But it seems from my reading that the clinical data ought to be available for inclusion in the 510k application by mid to late April. How about getting the whole thing ready to go so that it can be submitted before the end of May or the beginning of June? Seems like Q2 is very achievable.

    I too am very optimistic about the possible BARDA grant. That news ought to be announced by April or so.

    I also think that the statement made in the AGM presentation remains operative: "Select a partner for distribution or licencing agreement in 2013."



 
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