Re: We might already be at 125 events....
posted on
Oct 25, 2017 01:04PM
Koo wrote "I believe the reason for delaying the FA was to include USA in the BETonMACE mix results, was it not?"
Well, seeing as we have heard nothing about US sites being active and enrolling patients, one must assume that zero USA patients have entered BETonMACE at this time. If it is true that no USA patients to date, and the FA is being delayed to ensure that adequate USA patients contribute a certain number of events to the FA, then we won't be seeing the FA in 2017. With only 2 months to years end, 0 USA patients and 0 USA contributed FA events, I don't see the FA happening until sometime H1 2018 if Koo's suggestion is true.
However, as myself and others have pointed out.....there are too many unknown variables right now to conclude much at all. DM wrote in the 7/25/2017 news release: "FDA approval to proceed with the Phase 3 BETonMACE trial in the USA is well timed and should not have a major impact on the total duration of the BETonMACE trial." How do you define major impact on the total duration? That news release statement came after the June 2017 BIO Internation presentation in which slide 19 showed original BETonMACE running Oct 2015 to Oct 2018 and BETonMACE USA running early 2019 to early 2021. Of course, that graph showing USA BETonMACE came from out of the blue and made us all scratch our heads. Then a few months later in the October 2017 BIO Investor Forum presentation we see on slide 18 no mention of BETonMACE USA anymore but original BETonMACE going from Oct 2015 to mid-2019.
Interestingly, on both slides 19 from June and slide 18 from October, we see that the estimated EU approval for use of apabetalone for ACS is mid 2020. However, the USA approval moved from 2022 in the June slide 19 to early 2021 in the October slide 18.
This may have been suggested before, but could it be that the EU/Asia part of BETonMACE finishes and reads out in 2018 prior to the USA part of BETonMACE reading out in 2019?
BearDownAZ