Re: Last hour.....
in response to
by
posted on
May 31, 2019 06:28PM
“Based upon guidance from the United States Food and Drug Administration (FDA), an analysis of retained eGFR demonstrating an improvement versus placebo after one year of bardoxolone treatment may support accelerated approval, and an improvement versus placebo after two years of treatment may support full approval.”
Yes, I would agree and have been trying to hammer this point home for a while.
If Apabetalone is successful in retaining or even improving GFR to a significant degree, the drug could get a breakthrough designation and approval from the FDA.
This is a well designed trial with multiple shots on net.
bfw