Re: Futilitcy analysis
in response to
by
posted on
May 12, 2017 11:23AM
Hartland, I will try my best to respond to your questions.
"Did the company over parse the data to get the RRR." I think the post-hoc analyses for plaque reduction and 5-point MACE were very informative and valid. But it is always going to be difficult to extrapolate incidence of death, MI and stroke in a larger Phase 3 trial in high-risk patients from a 6-month long study in not-as-high risk patients.
"Am I wrong in assuming the medical community would have a Predicted number of 3 point Mace in say 1000 patients in one year?If so given they would know the Average patients enrolled, the average time such were dosed,and the number of 3 point events that have occured.Therefore if this has exceeded the Predicted number this would be positive for Rvx.I know what I am trying to say I hope you do.The longer it takes to get the 125 events would sem to me to be desired (especially for the patients"
Read my posts in this thread. Lots of info there that goes into detail.
"The Renal delay confuses me as the FDA is onside and the possibility of success seem high.We need other Irons in the fire." My opinion is that this trial is ready to blast off once funding is resolved, as suggested by Tada here.
BDAZ