Timothy Chiang's questions to Outlook Therapeutics (OTLK) leadership • Q3 2024
Question
Timothy Chiang asked about the outcomes of the recent Type C and Type D meetings with the FDA and whether there was a correlation between these discussions and the BLA resubmission timeline being moved to Q1 2025.
Answer
Executive C. Trenary clarified that there is no correlation between the FDA meetings and the filing timeline; the delay is solely related to the projected completion of trial enrollment. He characterized the FDA discussions as very positive, confirming they have reviewed every CMC question from the CRL with the agency and are satisfied with the outcomes.