"Plus, with 9 DSMBs ALT does not seem to be a problem? Question marks because I want to understand if my thinking is on track. If so, it sounds like it may not be an issue for BoM."

Is it a problem for the DSMB? Probably not since there have been 9 positive DSMB reports and Dr. Paul Watkins, former head of the FDA liver injury department is a member of the BETonMACE DSMB.

Is it a issue for drug approval? Yes and no. If BETonMACE behaves like prior trials, then apabetalone will raise ALT in significantly more patients than placebo. If so, there may need to be a warning label on apabetalone for docs and patients to closely watch liver enzymes. 

Is it an issue for investors, clinicians and press? To be determined. Most aren't familiar with the apabetalone story. I wouldn't be surprised if there may be some transient, knee-jerk reactions to any potential BETonMACE findings that apabetalone raised ALT in significantly more patients than placebo. Hopefully BETonMACE scores a huge %RRR so that the focus is on the MACE reduction and not the ALT.

BearDownAZ