Just received from Sarah- BOM QueriesHello GV,
In general clinical terms, completion of a study is typically defined as when the final report is issued from a clinical research perspective. As in BETonMACE, there are milestones within the study, which we have defined, and all material information / developments will be publicly announced in a timely manner once known. The Company has not publicly disclosed adjudicated vs. unadjudicated when we refer to events.
Please find below some FAQ regarding BETonMACE:
* The trial will continue until 250+ narrow MACE events have occurred (estimated in H1/’19); narrow MACE events stand at over 220.
* We have not publicly disclosed the breakdown between adjudicated MACE events vs unadjudicated.
* adjudication of all 250+ MACE events is expected to take 2 to 3 months post trial completion.
* Top line data will be announced after adjudication completion, database lock and analysis.
* All material information / developments will continue to be publicly available in a timely manner once known.
* There is no hard stop at 3 years of dosing as the trial is events based. Patients remain enrolled until a MACE occurs. Adjudication and safety follow-up can occur simultaneously.
Regards,
Sarah
G1945V