Re: You're right 10bagr, you didn't sway me....
in response to
by
posted on
Feb 02, 2019 08:07PM
Lets say, right now we are at 245 adjudicated events done and we have 35 non adjudicated events waiting to be processed. All 280 patients are still being dosed at this time. Monday 5 more cases from the non adjudicsted group are confirmed and added to the adjudicated group to bring the number of confirmed events to 250 which means all patients stop taking Apabetalone. At this point the 4 to 16 week exit review can start for all patients except the remaining 30 from the non adjudicsted group. This 30 must be adjudicated first before they can start the 4 to 16 week exit review. Any of this 30 patients that prove through the adjudication they are events, will be added to the 250 confirmed events, possibily raising the total number of adjudicated events as high as 280 if all 30 of non adjudicated events are confirmed. So my question is, if it takes two to three months to adjudicate an event and then four to sixteen weeks to complete the exit review, does that mean we will have to wait until event 280 finishes the exit review before they will lock results. if so we are max three months to adjudicate the last patient event and up to four months to complete the exit review meaning no data or results for seven months from the time we hit 250 adjudicated events. Open for comments on this.