well i'm worried, page-3

You are on a limb with this one.

You either believe in the product, or you don't. FDA approval will, or not, be forthcoming as FDA determines.

I understand that FDA are a rule unto themselves which is why approval adds so much to the value.

Maybe you should think about what the value is if FDA approval is not forthcoming. Be assured there is still very serious value - though mabe a different timeline to the one we would all like.