Re: Lowest volume in a long time?
in response to
by
posted on
Dec 18, 2018 10:16AM
",it was interesting to hear back during the AGM that those on 208 wanted to remain on 208. Who pays for such if particpiants did remain on this drug. Did they stay on 208? Would the trial schedule be maintained with the same clinics administrating?,,,It must be assumed if any did remain on the trial dosing schedule they would still become part of the data collected and if so it must be assumed there is a cost involved. Just thinking."
The BETonMACE trial protocol was amended to allow >104 weeks dosing and the relevant amendments will be posted to Clinicaltrials.gov in early 2019 according Resverlogix IR. All three recent BETonMACE posters presented at AAIC, ERA-EDTA and AHA reflect that BETonMACE patients will now remain on placebo or apabetalone for the duration of the study (minimum 24-26 weeks; max 36-38 months) until 250 events are reached. The 24-26 weeks and 36-38 months ranges are due to slightly different info in the posters. The trial figure in the ERA-EDTA poster still shows the old up to 104 weeks language (as does the December Resverlogix Corporate presentation), but the "Results" text in the bottom left hand corner of the ERA-EDTA poster indicates the 6-36 month dosing range. The latest poster is the AHA one, which indicated a 6 months to 38 month dosing range, with mean dosing period 26 months. Therefore, I interpret this as all placebo and apabetalone patients are continuing on their respective treatment until 250 events have been reached, Resverlogix is paying for this, the same clinics are involved, and the extended dosing data is still part of the ongoing and final BETonMACE trial data.
By the way, the December corporate presentation now indicates last dosing expected in H1 2019; no longer by end of 2018.
BDAZ