To ad to this excellent post.If by chance the fda approval does not go thru,the device could still be marketed in other countries.I believe the approval will go thru.
I don't know if there's any significance to another company which seems to be involved in the medical isotope/brachytherapy area. But ISR(Isoray) has had big developments occur in FDA clearance in many recent months. I bring this up because there is a high anticipation for its pps to move big, so I wonder if that could play in favor here too. On top of that I just realized the two companies happen to be located just 10 miles apart which seems ironic or maybe the two headquarters location (which is in Washington state) is nicknamed Isotope Valley