Biocardia Announces FDA-Recommended Modifications to Primary Endpoint for Cardiamp Cell Therapy Heart Failure Trial to Support Marketing Approval
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: GlobeNewswire
SAN CARLOS, Calif., April 30, 2020 (GLOBE NEWSWIRE) -- BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported that it has accepted and implemented FDA-recommended modifications to the primary endpoint for the CardiAMP® Cell Therapy Heart Failure Trial and associated statistical analysis plan. The Agency proposed these modifications to support the potential for marketing approval for the therapy based on the currently enrolling pivotal trial. The primary endpoint going forward will be an outcomes composite score based on a three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis, an established outcomes design that has been used in other leading heart failure programs. The FS procedure is a ranked analysis that first compares each subject to each other subject for occurrence of first-tier events (time to death, in this case) and then compares patient outcomes for subsequent tiers. The ti
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