Topcoin, thanks for the heads up on the Reata news release for the launch of their Phase 3 FALCON trial testing bardoxolone methyl in patients with autosomal dominant polycystic kidney disease (ADPKD). And bfw, thanks for the comment putting this Reata clinical endeavor in the context of apabetalone.

A few issues to consider. 1) Change in kidney function (eGFR) is a secondary outcome measure in BETonMACE and is not a primary outcome measure; 2) Because of #1, a follow up Phase 3 trial for apabetalone may be necessary for marketing/label indication beyond the MACE indication; 3) Because of #1 and #2, stellar CKD sub-study data from BETonMACE may have no bearing on FDA approval or rate of apabetalone approval for MACE indication; 4) FALCON trial is specific for patients with ADPKD, which might be a more rare form of kidney disease for the FDA to give special consideration; 5) What do I know? I could be way off base and wrong in a lot of these assumptions!

Have a great weekend all,

BearDownAZ