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Message: The last DSMB update of Feb 26th....

Four months is a long time to wait, but if another update is coming it shouldn't be long now.  The 6th update included some interestsing points:

"The BETonMACE phase 3 trial now has over 2,300 patients enrolled, representing over 95 percent of the approximately 2,400 patients outlined in the study protocol. We are currently considering the extent to which we enroll beyond 2,400 patients to ensure BETonMACE yields 250 MACE events optimally and to include US patients. We now have patients that have been on treatment with apabetalone for nearly 120 weeks, which is nearly five times longer than any treatment duration in any of the Company’s previous Phase 2 trials. Full enrollment continues to be anticipated in the first half of 2018," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.

Assuming another update is coming I'm guessing it will note that BETonMACE is now fully enrolled, and the longest number of weeks some patients have been enrolled is now apporaching 140 weeks.

And on February 26th they were "considering" the extent to which they would enroll beyond 2,400 patients.  The way its written I think anticipating an increase in enrollment was pretty logical.  However I think its also very possible that the extent to which they decided to enroll beyond 2,400 patients could very well have turned out to be 0.  Especially considering Don's assertion during his public presentation in May at Bloom Burton that BETonMACE is "properly powered" at 2,400.

We shouldn't have to wait too long to find out in any case.  Whether its with another DSMB or a SSRA....eliminating the uncertainty of whether or not BETonMACE needs more patients will be a big plus in my eyes, especially if after "considering" all the information the determination is that no additional patients are needed.  

 

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