I really have no idea about our odds of success with FDA.
HDE is designed for rare illness with few or no options and cholangio is certainly that. And distal cholangio is reasonably similar to pancreatic ca.
But it would’ve helped to have done a few elsewhere.
I know OSL has good people working on the submission.
Maybe with tight entry criteria and post treatment surveillance they might get it through.
Thing is, it’s company making. If they get FDA for this it will be in the hands of US clinicians and the game is on.
Ann: Two more PANCOSIL Trial treatments using OncoSil device, page-20
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