So much for the trains running on time at the FDA, as the agency notifies Kalvista that it will be unable to issue a decision on their therapy by the PDUFA date by June 17 because of a “heavy workload and limited resources.” The regulator expects to deliver a verdict within about four weeks, Kalvista said. https://www.businesswire.com/news/home/20250613608281/en/KalVista-Pharmaceuticals-Announces-FDA-Will-Not-Meet-PDUFA-Goal-Date-for-Sebetralstat-NDA-for-Hereditary-Angioedema-Due-to-FDA-Resource-Constraints
Four weeks may not seem a lot to outsides (though every day of delay counts when you are talking launch plans) but I am thinking this is not the last, or the greatest, of delays ahead.
Investigations of a Dog 