RE:Just received from Sarah- BOM QueriesThanks for sharing that response from Sarah GV. Nearly identical to two responses I got from Sarah (see below). Seems that they have a standard response to inquiries right now!
Friday 2/22: "
Thank you for following up. Please find below some points 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."
Tuesday 2/26: "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."
I sent a follow up and am awaiting response. I asked:
"Is end of dosing in BETonMACE considered material information/material development requiring public disclosure?
Does the final 2-3 month adjudication and safety follow-up periods, which you stated can occur simultaneously, only start upon end of dosing?
Is last patient visit (end of safety follow up period) considered material information/material development requiring public disclosure?
Is reaching 250 adjudicated MACE events the trigger for end of dosing in BETonMACE?
Is reaching 250 adjudicated MACE events in BETonMACE considered material information/material development requiring public disclosure?"
BearDownAZ