A few clarifications from IR
in response to
by
posted on
Mar 01, 2019 05:12PM
I received some answers from Sarah regarding my questions from earlier in the week. Very helpful. Though there is still some ambiguity surrounding the "250" vs. "250+".
Is end of dosing in BETonMACE considered material information/material development requiring public disclosure?
It would be our intention to announce when we reach 250+ narrow events which will likely include info relating to end of dosing.
Does the final 2-3 month adjudication and safety follow-up periods, which you stated can occur simultaneously, only start upon end of dosing?
Adjudication is ongoing as events occur. The follow-up period, which includes the usual safety checks, differs for each study participant and is after dosing is completed.
Is last patient visit (end of safety follow up period) considered material information/material development requiring public disclosure?
This would not require public disclosure.
Is reaching 250 adjudicated MACE events the trigger for end of dosing in BETonMACE?
We have stated that the trial will continue until 250+ narrow events have occurred, however we have not publicly disclosed adjudicated vs. nonadjudicated.
Is reaching 250 adjudicated MACE events in BETonMACE considered material information/material development requiring public disclosure?
Yes we plan to announce when we reach 250+ narrow events.