I think that if it meets the trial endpoints specified in the SPA, how can the FDA say, "No" to approval (albeit, they are one of the most incompetent, possibly corrupt, organizations in government).
I can't see how Merck could go to the FDA for an approval if it doesn't meet the endpoints. Can you actually take a failed Phase 3 trial, and "data-mine" the subsets, and say, "well, it worked in liposarcoma, where it met the endpoints by a wide margin, but failed in osteosarcoma, so, you should approve it for liposarcoma."??? I don't think you can. Had Merck/Ariad done a sub-set type of trial like the PACE Trial for '534, it would have been much easier to pull something like that off.
I still lean toward a success in the SUCCEED trial (because of my long position)(as well as "hoping" the P2 data holds true and we get lucky), but I just don't give it much more weight than 60%....again, just my guess that's all. And despite disagreeing with Don about all this, I do hope he is right....
