510k application

Its` been near six months since the "Novosorb" wound trial. I would have thought that would be long enough to answer all the questions for the FDA 510k application to sell the dressing in the US. CZD said the application would be complete by third qtr 2013. Time is nearly up so I hope there haven`t been any hiccups here. I hope Polynovo are already filling in the questions for the 510k for BTM used in full thickness surgical wounds in anticipation of the successful conclusion of that trial so there isn`t the same time taken as with the dressing application.