barsax - I agree with your comment that a BETonMACE2 trial could be haulted early for overwhelming efficacy. This could have the effect of cutting a BoM2 trial down to 18 to 24 months and save many millions. I think the BETonMACE trial gave the FDA enough safety data that having a shorter BoM2 trial that continued to show the same trends in an expanded trial of the same trial populations that responded well would allow them to be satified. 

Another thought was that an NDA may be filed early but the trial may continue and reaching whatever goals of BoM2 would expand what may have been a narrower lable.

tada