Replies to post #10790 on Ariad Pharmaceuticals Inc fka ARIA

[biomaven0]

ARIA is required under FDA statutes to conduct a confirmatory study to support accelerated approval of ponatinib

Yes - accelerated approval always requires a confirmatory study. What is unusual here (if this report is correct) is that it looks like Aria is trying to have this confirmatory study do double duty - not only confirmatory of the label they are going for (3rd line) but also attempting to expand the label to frontline and 2nd line.

I personally think broad frontline is a bit of a chimera given Gleevec is going generic. I think the best they can hope for is high risk frontline and broad 2nd line. If they can achieve that then the drug should eventually achieve > $1B annual sales in CML and shareholders will all be more than happy no matter what happens with their other drugs.

The fact is that it is a lot easier to go up against Gleevec and demonstrate superiority (rather than just non-inferiority) than going up against the 2nd line drugs. So even aside from the regulatory aspects the Gleevec comparator is the sensible trial to go for. (It's a bit analogous to the prevailing criticisms that Aveo should have gone up against Sutent instead of Nexavar in its current trial - sometimes analysts and "experts" just don't seem to get the strategic aspects of optimal trial design.)

Peter