Toniv wrote: "If BoM passes FA there is still 18 months until the end of the trial. Lots of time for investors to sit on the sidelines."

Toniv, this is an event driven trial. Right now, the protocol states to that the trial completes at 250 events. ClinicalTrials.gov lists October 2018 as trial completion date, but this hasn't been updated since July 2016. Keep in mind that the rate of MACE event occurence increases as the trial gets closer to full enrollment. Full enrollment is expected Fall 2017. We don't even know yet how long it will take to get to 125 events. There are too many unknowns to make a statement that the trial will take another 18 months. Could be 12 months, 15 months, 18 months......we don't know. Also, keep in mind that there are likely going to be some changes to the BETonMACE protocol based on the wording of the recent Resverlogix news release regarding the FDA decision. This may or may not delay the anticpated completion date, but these protocol changes and their impact on the completion date are not public knowledge yet.

"If FA passes in terms of safety but the efficacy impact is minimal it would seem to me that someone needs to make a decision as to whether to continue investing in the trial but how does management do this if they do not know the stats?"

The futility analysis is more concerned with efficacy. The DSMB is entrusted with making an informed suggestion, based on their analysis of the data at 125 events, as to whether there is a decent chance of the trial meeting its primary endpoint/outcome. Clinical trials are risky endeavors. There is no guaranteed success. Just look at how many Phase 3's have passed futility analyses but still failed to meet their primary endpoint/outcome at the completion of the trial. Management gets advised by the DSMB and if BETonMACE passes the FA, then we know there is still a chance of BETonMACE succeeding. Keep in mind that right now in the protocol, there is a 175 sample size estimate analysis scheduled as well. So there is another DSMB check there to alter the trial to add more patients in case the stats are seeming promising but questionable. Lastly, keep in mind that there are likely going to be some changes to the BETonMACE protocol based on the wording of the recent Resverlogix news release regarding the FDA decision.

BearDownAZ