Re: Clarification received...
in response to
by
posted on
Jun 10, 2018 08:51AM
"So if this is correct and neither of these two happens what do you conclude from that.?is it a good thing or not?"
I don't know if I can provide an objective answer to your question. Subjectively, whether foregoing the FA/SSRA is a good or bad decision depends on what the results of the hypothetical FA/SSRA are and whether BETonMACE is ultimately successful. I know, useless answer right? I don't know how else to respond.
"I understand from what you have said we may go to top line data as soon as 250 events occur."
We will go to top line data as soon as 250 3-point MACE events are adjudicated. That part of the trial design has never wavered or been in question. The caveat being if a SSRA does still occur and this hypothetical SSRA suggests an increase in total MACE events beyond 250 and Resverlogix/CSC accept the recommendation.