Re: Resverlogix to Present at the Clinical Trials on Alzheimer's Disease Congress 2019
posted on
Dec 02, 2019 09:07AM
"Except that when Dr Cummings says "promising", it reminds me of what Dr Ray said...promising and needs another study with 5000 patients and 500 MACE events. I sure hope we don't get another "underpowered" study!"
Big difference there is that MACE data was the primary endpoint; we were all betting on success in MACE primary endpoint for supporting FDA/EMA approval for cardio indication. MoCA changes are an exploratory endpoint, not primary endpoint. There was always going to need to be a follow up registration trial for cogntion.
Slide 13: "Cognition assessments are pre‐specified in statistical analysis plan (SAP) facilitating expedient development to confirmatory registration trial(s)"
https://www.resverlogix.com/upload/event/42/4388386bbd26/2019-03-29---ad-pd-2019-cummings-final.pdf