What do you think about the NICE incentive that seemingly places companies in the strange position to leave their OS blinded longer in order to get more monetary valuation on their product?
Well, I have seen at least one trial with different primary endpoints on opposite sides of the ocean.
I think they handled it as co-primary endpoints but the OS was for european registration. (or perhaps it was the other way around). I don;t remember which drug but recall it being very odd whe I saw it.
regarding EU you ask:
How would they make a fair determination when a crossover is in play?
You would need to look at QALY calculations to figure that one out. I haven't looked at that to see how they handle PFS and x-overs.
Finally, why does a company like AZN, in their most important MYSTIC trial, believe they can unveil PFS ahead of OS. Other than market confidence, what advantage does it bring them?
This frequently happens (Avaglio released PFS results a year before OS results). Perhaps for Mystic the advantage is to allow the start of a rolling BLA. You also have to remember the available therapy issue for AA. If someone else beat them to full approval they would need OS anyway (because the available therapy clause would block them from AA). But let's not go there again, LOL.
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