Whichever probability you place on the potential outcomes of...

Whichever probability you place on the potential outcomes of approval vs non approval capital raising is a key issue to consider in the downside scenario.

scenario 1: successful Ce mark - followed by immediate capital raising at much improved share price - smiles all round

scenario 2 - fail to get Ce mark, depleted funds exacerbate negative position, share price drops like a stone. No cash, no product, no future.

Note to to all - I am not trying to down ramp, having weighed up risk/reward I plan to be getting back in at right price before decision .

But it being a realistist the overly long wait and depletion of funds mean this is more than ever before an all or nothing proposition. Ie even if approval failure is only 5-10 % probability lets be honest - if it does happen you won't be able to give the shares away.