Sorry to start a new post, but I can't find the original to...

Sorry to start a new post, but I can't find the original to refer to.

Over the past couple of weeks there was a point raised about the ethics of SOC, and thus how could pts be given an alternative to the SOC - Soarfenib.

A theory - in the US the FDA would not allow this trial for the above reason. The French I assume can ignore SOC if they had been convinced that the alternative is viable?

I suspect that the FDA would allow SARAH result to be a surrogate, and thus a new indication would be possible without a trial in the US. Assuming we get some good data.

Due to the population mix, and type of HCC, I don't think the FDA would be so interested in the SIRvenIB data, but it could do little harm.