Feb 10 (Reuters) – The U.S. Food and Drug Administration will not review Moderna’s (MRNA) approval application for its influenza vaccine, the company said on Tuesday, sending its shares down 8% in extended trading.
In its refusal-to-file letter, the FDA said Moderna’s choice to compare mRNA-1010 to an already licensed standard-dose seasonal influenza was the sole reason for the refusal to initiate a review of the application.
The letter specifically cited the lack of an “adequate and well-controlled” study with a comparator arm that “does not reflect the best-available standard of care,” Moderna said.
https://finance.yahoo.com/news/fda-refuses-review-modernas-influenza-000958036.html