Nov. 10 at 2:10 PM
$DNLI The 3-month PDUFA delay to April 5, 2026, is frustrating but fundamental thesis remains unchanged.
Crucially, the delay is purely procedural due to a "major amendment" of additional data, NOT due to any safety or efficacy concerns. The science is solid.
More time for waiting, but the potential validation for the entire BBB platform is still the main event. Patience is key.