I have always thought that the (anecdotal)evidence from the 60+/- eind patients, being so positive, should have given the DSMB cause to watch the CD-12 trial very closely. After all, the whole world knows the s/c patients are at risk of morality(around 20%+). So when an allegedly promising game changer sooner starts a trial and puts the FDA on notice, why not have the safety board jump on the mortality outcomes? Think about the fact that at 20% mortality in the placebo arm that would mean 13 dead patients (assuming 65 pts in placebo group vs 130 in LL group) at the interim "check point". And the best case scenario for LL could be ZERO dead. Excuse me, hello, any lawyers on the board? Doesn't that sound pretty neglectful on the FDA's part. I sure would be pissed if any of my family were in the placebo group that died, especially if they were anywhere after the first or second deaths while there were no deaths in the LL group. I'm sure there is someone on our board that knows some medical malpractice attorneys that could look into something like this...or not???