BioCardia Provides Update After Recent Consultation With Japan's PMDA; Says PMDA Signaled That Data From Outside Japan Is Likely To Be Sufficient For CardiAMP Autologous Cell Therapy Approval
Portfolio Pulse from Benzinga Newsdesk
BioCardia, Inc. has announced that following a recent consultation with Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the PMDA indicated that data from outside Japan may be sufficient for the approval of BioCardia's CardiAMP autologous cell therapy. This development suggests that BioCardia may not need to conduct additional clinical trials within Japan, potentially accelerating the approval process for CardiAMP in the Japanese market.
November 29, 2023 | 12:10 pm
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POSITIVE IMPACT
BioCardia's recent update indicates a positive regulatory development in Japan, which could lead to a faster approval process for its CardiAMP cell therapy in the Japanese market without the need for additional local trials.
The news that Japan's PMDA is open to approving CardiAMP based on data from outside Japan is a significant positive development for BioCardia. It implies that the company can avoid the time and expense of conducting new clinical trials in Japan, which is likely to be viewed favorably by investors. This could lead to a shorter time to market and reduced costs, positively impacting the stock price in the short term.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 90