Aug. 26 at 4:01 AM
$BTAI 3. FDA Alignment on Trial Design: The company has had meetings with the FDA about the trial design. This means the structure of the trial—the number of patients, the endpoints being measured, the duration—is something the FDA has likely agreed is a "reasonable approach" to support a label expansion. This reduces the risk of the FDA rejecting the application simply because they didn't like how the study was run.
