Dec. 25 at 3:52 PM
$OTLK
After the FDA issued a CRL for ONS‑5010 (OTLK’s wet AMD biologics application) in August 2025, Outlook Therapeutics:
Requested a Type A meeting with the FDA to clarify what evidence or changes would satisfy the agency’s concerns from the CRL (about insufficient evidence of effectiveness).
Reddit
The purpose of that meeting was not just to talk, but to identify exactly how to address the remaining issues so the BLA could be successfully resubmitted.
They characterized the meeting as productive and used the feedback to build their resubmission, which the FDA later accepted as a Class 1 resubmission (i.e., minor clarifications) rather than Class 2.
Reddit
This is exactly the type of regulatory roadblock and response for which Type A meetings are designed: a stalled approval process after a CRL, requiring clear FDA guidance to move forward.
