Re: Take Home Points: not ready for use in patients
in response to
by
posted on
Nov 16, 2019 05:50PM
Despite all the chatter, the data so far pretty much falls in line with what this board had expected; particularly given the trial ended up with a low power because of a less sick placebo group.
Sure, there are issues of magnitude (some had suggested 30% RRR while we got 18 to 21%; and no one has yet to comment on the MACE data ex stroke) but to me there is only one that is a real surprise and I would appreciate some explanation/speculation on this.
My question is about the eGFR data for the drugged group (page 15); it is -0.4 vs +2.1 for the placebo. Given all the data from Phase 2, this is the only one that bothers me. To offset it, the 50% RRR of the low eGFR group goes some way to reduce my concern. Still, how did our drug end up reducing eGFR for 1212 patients...and on top of that...INCREASE it for the placebo group? It almost feels like someone made a mistake and they got the sign reversed for the two groups.
And if the eGFR bio marker did not go the expected way, then it leads me to wonder about the Vascular Dementia forecast. Perhaps Apabetalone is not the next Humira in the making after all?
Thanks!
Iconoclast