BIOCENTURY reports that FDA cleared Saol to resubmit its ultra-rare disease NDA, reducing the need for a new trial. The update is framed as another reversal in the so-called “Makary era” approach to regulatory decisions, where FDA activity can shift requirements after earlier positions. For Saol, the clearance changes the development path by dropping the demand for a new study and enabling a resubmission under revised expectations. The report highlights how quickly ultra-rare development timelines can pivot when regulatory feedback changes. The case reinforces the importance of NDA design and the ability to adapt clinical packages rapidly when FDA requires additional evidence—or later withdraws those demands.