Re: Renal trial delayed (again)
in response to
by
posted on
Sep 28, 2017 05:24AM
"The good news here is that they already have a renal trial going on within the BETonMACE trial."
Yeah, but those are just secondary renal outcome measures in Phase 3 BETonMACE. The pending renal trial is a Phase 1/2 trial. It seems they have to repeat the pharmacokinetic study (that had already been done in the New Zealand Phase 1) in part A of this pending trial before proceeding to the Phase 2. Secondary outcome measures in a Phase 3 are great, but not the same as the clinical success of achieving primary outcome measures of a Phase 3 trial. They are a long ways away from starting a Phase 3 renal trial. Plus, they are different patient populations in BETonMACE and pending renal trial. Diabetic patients with recent ACS in BETonMACE; end-stage renal disease patients on dialysis that have not had ACS in past 6 months for the pending renal trial.
"Looking forward to the futility analysis any day now."
Maybe, maybe not. My initial projection of end of September was based on the 125 event (50% of 250) target. But as we discussed before, it seems that the DSMB and Clinical Steering Committee are in discussions to potentially delay the futility analysis until some yet to be announced point between 50% and 75% of events. So much uncertainty surrounding the futility analysis, inclusion of US patients, changes to BETonMACE protocol and how all of this affects the letter of intent for the "strategic transaction."