I pulled the trigger and bought in to this company as it is...

I pulled the trigger and bought in to this company as it is right up my alley (I am a Nuclear Medicine Tech and prior to that completed a degree in Pharmaceutial Sciences). I feel that breaking into US markets and obtaining FDA approval for Aussie tech is indeed quite challenging, just recently Cyclopharm's technegas (another aus nuclear medicine company) received a complete response letter from the FDA, however being "nuclear" has nothing to do with it (technegas has been around for years in Australia, nuclear medicine in general for decades). In fact I feel that the USA are far more advance than Aus in regards to PET/nuclear medicine research and clinical availability.
I believe TLX could become the next Sirtex for which they obtained FDA approval for their product in 2002, probably even greater seeing as they have more coming in their pipeline.