What does today's no safety concern statement mean for apabetalone? Previous Phase 2 trials only went out to ~ 6 months of treatment (ASSURE trial). Not accounting for any patient deaths or discontinuations, and assuming that patients are on drug until end of trial.......apabetalone treatment has not given rise to any safety concerns in patients treated up to ~33 months. Based upon company news releases or statements at Corporate Updates, here are the estimated number of patients in each "wave." Keep in mind 50% are on apabetalone and 50% on placebo:

600 patients: At least 22 months, up to ~33 months

600 patients: At least 16 months, up to 22 months

750 patients: At least 9 months, up to 16 months

450 patients: At least 4.5 months, up to 9 months

The last wave I cut off at the new release on 3/19/18 and assumed 2400 patient total. By the time of the AGM on Sept 12th, nearly all of the 2400 patients in BETonMACE will have exceeded the ~6 month dosing period in the previous Phase 2 ASSURE apabetalone trial. So for today's 7th DSMB to again state no safety concerns is a great sign for the long-term safety of apabetalone.

Because of the above range in each wave, and other unknowns such as patient deaths and discontinuations, it is uncertain how many exact patient years have been accumumulated. My conservative estimate is 3200 and 3800 by end of Q3 and Q4, respectively. Again, this assumes that patients are on treatment until end of trial and not stopping at 2 years of treatment. Keep in mind that the endpoint is 250 3-point MACE events, not accumulation of patient years. So patient years are not as important as the estimated, but unknown, placebo event rate and % by which the apabetalone reduces this event rate. 

I really hope that SSRA comes soon (and with good news). The significance of the SSRA is huge, IMO. Without the SSRA, there are a lot of unsettled unknowns. Will enrollment be increased beyond 2400 patients and will target 3-point MACE events be increased beyond 250 events? If so, what are the financial costs and timeline changes associated with this? SSRA announcement would time stamp 188 events and give investors more confidence in when the 250 3-point MACE event target would be reached. Enrollment, MACE target #, cost, timeline, status. All these things could potentially be answered by the SSRA. 

BearDownAZ