ACS is admittedly not my strong suit but my 2 cents
primary endpoint agree - it is the registrational endpoint
i think comparator will be angiomax in a PCI setting. i think they might be able to scale it up to show superiority since the rub with angiomax is slightly higher arterial thromboses (?inc MI and stent occlusions), although angiomax consistently bests UH on bleeding. so if going for superiority they will need to push the dose up. they could also jsut as well go for a non-inferiority vs angiomax - which would be significant i think since m118 can be given as AC in the ER for ACS and then makes the transition to PCi seamless if as good as angimax (which has short half life and not good as general anticoagulant in ACS)
my thoughts on dose in general (and i would have to reread the paper) but the 50 arm didn't do as well as UH on several important endpoints, the 100 had more bleeding, so the 75 seems to be the right dose (although they might take another look at the 100 dose since many of the bleeds if i recall were minor and at the catheter site, so all they would have to do is wait a bit or reverse the agent before taking catheter out)
again i am not that knowledgeable in this area so take it fwiw (and i am sure someone will respond to this and point out the many flaws in my reasoning)
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