June 9th NR
posted on
Jun 14, 2020 10:44AM
Don mentionned it during the webcast but I discarded it because of his puffery past.
But KKZ saying: “For the first time in patients with a recent Acute Coronary Syndrome with diabetes and stage 3 CKD co-morbidities, we observed a 50% reduction of MACE by a medication, apabetalone treatment. This is important as this patient population is known to have significantly higher CVD risk compared to non-CKD patients and being less or non-responsive to the standard of care or other emerging therapies,” stated Dr. Kam Kalantar-Zadeh.
Similar finding to this analysis was reported in the US Renal Data System 2016 analysis where the total number of individuals with CKD Stage 3 in their system was 1,903,500, and far fewer individuals had CKD Stage 4-5; 330,140. One interpretation for the massive difference in CKD3 to CKD4-5 is premature mortality.
My boldings, I've overlooked these part when reading the NR, looking for eGFR results. That's a beautiful market for apabetalone, without competition, with an increasing market (ABL impact on patients, keeping them alive).
I'm really surprised we need another trial to go forward with that kind of impact over current therapies.
- Confidence interval says 95% of the time, MACE RRR in CKD between 4% and 74%.
- No significant downsides
- No alternatives
Maybe I'm in denial mode, but after reading FDA guidelines, I would love to know why not.
That slide is also misleading me into believing RVX in approval mode.