Theraspheres and FDA approval, page-4

Not calling anyone a donkey and not underestimating the importance of RCT.

Its hard to find RCTs involving TheraSpheres but

SORAMIC was an RCT (419 patients) conducted in Europe that showed no difference with theraspheres

And STOP-HCC RCT of TheraSphere - which hasn't reported. This is for HCC. They are waiting for the 417 patients to complete survival analysis

I'm not an expert on them and I don't know what FDA have required of the company and what has been done through investigator sponsored trials.

But despite that, FDA has approved them.

Just reflecting on the possibility that the FDA might - I mean might - have a less rigid approach to the approval of Oncosil treatment than we expect. That's all I'm saying.

But yes, I did think that as far as one sided studies go, a one sided study with 200 patients for HCC (which is commoner than ca. pancreas) compares reasonably with a 50 patient study for ca pancreas.