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Monday, 10/17/2022 9:15:43 PM

Monday, October 17, 2022 9:15:43 PM

Post# of 1569
December 13, 2022 as AdCom Date for Omecamtiv Mecarbil,
(from StreetInsider)
PDUFA of February 28, 2023

Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug Administration (FDA) has informed the company that the previously announced meeting of the Cardiovascular and Renal Drugs Advisory Committee to review the New Drug Application for omecamtiv mecarbil is currently scheduled for December 13, 2022. The FDA has assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023. Omecamtiv mecarbil is an investigational, selective, small molecule cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF).

The Dec 13 AdCom should give a good indication as to the true potential for approval by the FDA on or before Feb. 28th for omecamtiv mecarbil.

Getting close to some resolution, hopefully a positive one.

Best of luck with your investments!
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