Ann: OncoSil TGA regulatory update, page-36

If FDA accepts downstaging to surgery as a primary outcome, which I think is the current strategy in RCT negotiations, then it won;t take as long as it otherwise could.

In that sense, the Panco study helped find a better (proxy) primary outcome than overall survival.

However, it shows why the CE Mark was a close run thing. At least the Europeans have ultimately balanced the potential benefit of a safe intervention in a desperate situation.

FDA might do the same for cholangiocarcinoma, which is a terrible and desperate disease. With no surgical intervention possible btw. The importance can't be overstated. If the company is granted HDE for cholangioca, it will open the door to off label use in the USA.

That's lost on TGA. We have very average bureaucrats here. Their default is that the safest way to cover their backsides is to be the last to approve anything.