AVITA Medical Earlier Announced It Received Notice From The FDA That Additional Information Regarding The PMA Is Required For Continuation Of A Substantive Review Of RECELL GO; Upon Completion Will Reenter The 180-Day Cycle
Portfolio Pulse from Benzinga Newsdesk
AVITA Medical has received a notice from the FDA requiring additional information for the continuation of a substantive review of RECELL GO. Once the information is provided, the review will reenter the 180-day cycle, according to an SEC filing.
October 02, 2023 | 5:19 pm
News sentiment analysis
Sort by:
Descending
NEGATIVE IMPACT
AVITA Medical's RECELL GO review by the FDA is delayed due to additional information requirements. This could potentially delay the product's market entry.
The FDA's request for additional information indicates that there are still unresolved issues with AVITA's RECELL GO. This could potentially delay the product's approval and market entry, which could negatively impact AVITA's stock price in the short term.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100