Re: Breakthrough Therapy Designation Application
in response to
by
posted on
Dec 06, 2019 12:17PM
Thanks BDZ....
So I'm wondering, on the cognition side we have a sub group of a sub group that showed promising results. Out of the 469 over age 70 patients there's a cohort of 97 (memory) that shows promise.
With CKD we have 259 patients....okay. Is it realistic to hope that we could see broad based eGFR improvement in the dosed patients over placebo +SOC? I'm not asking what anyone thinks the numbers will be, or how much improvement might be shown. What I'm wondering is....is there a chance that we could see numbers reported that are relective of ~130 dosed versus ~130 control group?
I'm also remembering DM saying it was the Kidney data that had some wanting an embargo until the spring....the point of my previous post is that it might be one of those: "Give 'em the bad news first" scenarios....where we go from bad, to good, to great. The only fly in the ointment I envision would be if promising results are only borne out by a very small patient population as seems to be the case with the MoCA data.
BDZ please excuse my lack of near total recall or the ability to have all the information so well catalogued that it is easily retrievable....given that I'm very much a layman its hard to know what file folders to even put things in a lot of the time.