KOO - it appears from the HL doc that a Ph3 trial on the effect of ABL on CKD might be on the cards, suggesting CKD might be the basis of a BT designation.

Why the need for another trial if eGFR was increased in BETonMACE? Because eGFR is an estimate of true GFR based on serum creatinine, and as such might not be accepted by the FDA as proof of a beneficial effect. They might be asking for a new trial that specifically looks at true GFR (not eGFR) which is a little more complicated technically.