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Adding to the likelihood of approval is the fact that at least...

  1. 76 Posts.
    Adding to the likelihood of approval is the fact that at least 50% of the 120 day questions have now been completely resolved depending on what your definition of most is, as is inferred by the 30/09/2014 announcement.

    “Most of the issues raised in the 120-day questions have now been classified by the EMA as completely resolved”

    My only concern (and it’s a minor one at that) between now and CE mark approval is when the capital raising will be, I expect that we will need to raise something in the order of $15 to $20 million in order to fund US trials and allow for costs and contingencies until a self-sufficient cash flow is achieved, I suspect a reasonable time frame for this to occur would be 12 to 18 months from start of sales which are expected 1Q 2015. Hopefully we tighten our purse strings a little until start of sales so that the capital raising can be undertaken post CE mark, given the run in share price up to 0.45 with the anticipation of granting of CE mark at the 180 day mark one could expect that the share price will exceed 0.50 following approval, this will allow us to raise the required capital with as minimal dilution as possible, that is in the order of approximately 40m shares. If the capital raising is required pre CE mark then you could expect a raising of approximately 60m shares, as you can see it’s a only a difference of 20m shares out of already 260m odd shares on issue, thus you could say when the capital raising takes place is inconsequential.
 
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