Akebia Therapeutics Inc (AKBA)

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$AKBA from stocktwits FDA’S THREE ALARM FIRE- (a)FDA issued CRL to FibroGen & Roxadustat (Aug. 2021); (b)FDA issued CRL to Akebia & Vadadustat (March 2022); (c)FDA’s Cardiovascular & Renal Drugs Advisory Committee supported GSK’s Daprodustat for dialysis dependent patients w/ anaemia of CKD w/ 13-3 vote (Oct. 2022); (d)Akebia submitted FDRR w/ FDA’s Senior Advisor in agency’s Office of New Drugs (OND) (Nov. 2022); (e)CKD community & key opinion leaders such as Dr. Jay Wish criticize FDA decision making concerning HIF-PHI drugs (March 2022 - present). (FDA knows from data that Daprodustat is inferior to Vadadustat.) FDA’S RESPONSE TO FIRE - (a)FDA met w/ Akebia to discuss appeal & subsequently requested “additional clarifying information” (not ADCOM, not clinical trial, not denial) (Nov. 2022); (b)FDA assigned Dr. Peter Stein, M.D., Director of OND as deciding authority for appeal (Feb. 2023); (c)Dr. Stein provided Akebia/Vadadustat w/ clear path forward to approval (May 2023). GLTA