RE: re fda10 Mar 2016 17:26
There are two vital conditions which need to be satisfied before commercial sales can commence. The first is regulatory approval. Yes we have the EU mark, but we need FDA approval also, as further endorsement of the product as well as greater market potential. The second, probably even more important, is robust clinical trial data from the KOLs. As soon as the clinical trials from the ovarian cancer study are complete and assuming they are successful, then Angle can go full steam ahead in commercialising Parsortix into the clinical market in the EU initially. It all takes time but this should be a pivotal year for Angle.