SanFran, 

BETonMACE was originally projected to complete enrollment of the 2400 patients in H2 2017, hit the 125 event futility analysis mid-to-H2 2017, and hit the 250 event endpoint H2 2018. Of course, these are only projections based on expected enrollment and event rates. Actual enrollment and event rates may vary. Last update in March they had enrolled over 1200 patients. We keep hearing that Russia and Taiwan will start enrollment but to the best of my recollection no official word yet. And FDA/US involvement? Hopefully Monday's slides and/or the next BETonMACE news release will update us on current enrollment numbers and status of Russia, Taiwan and FDA/US. Tomorrow is ~3 months since last DSMB report, so we might get another one real soon and the associated news release may have enrollment update. The timing of the futility analysis and the enrollment numbers at the time the futility analysis is triggered will be very informative for redefining the anticipated trial completion. 

Assuming that trial completes in 2018, then Resverlogix will likely file the new drug application (NDA) with the FDA and marketing authorization application (MAA) with the European EMA in 2019.  NDA and MAA approval are required to allow apabetalone to be sold and marketed. This is different than an investigational new drug application, which is required to begin human trials of a new drug. 

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