Mar. 21 at 11:40 PM
$IBRX Sharing - FWIW
GROK input : regarding sBLA - Papillary
The FDA must notify the sponsor of its filing decision (accept for review or issue another RTF) WITHIN 60 calendar days of receipt.
With acknowledgment on March 9, 2026, this RESPONSE is EXPECTED by approximately May 8, 2026.
For efficacy supplements like this one (not an original NME BLA), PDUFA performance goals START from the RECEIPT DATE (March 9, 2026), NOT the 60-day filing date.
The review clock is:
STANDARD review: FDA aims to act within 10 months of receipt → target around January 9, 2027.
PRIORITY review: FDA aims to act within 6 months of receipt → target around September 9, 2026.
Priority review is granted if the FDA determines the supplement offers a significant improvement in safety or effectiveness for a serious condition (possible here due to the unmet need in papillary-only NMIBC, where cystectomy is often the alternative).
The designation is confirmed in the filing decision/74-day letter.
