Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that, in response to a request from the U.S. Food and Drug Administration (FDA), the company recently provided additional pharmacokinetic analyses of omecamtiv mecarbil related to the company’s new drug application (NDA). After an initial review of the company’s submission, FDA has communicated that the additional data provided constitutes a major amendment to the NDA and has extended the PDUFA date by three months to February 28, 2023 to provide time for a full review of the submission.
https://finance.yahoo.com/news/cytokinetics-provides-regulatory-omecamtiv-mecarbil-113000740.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.