Outlook Therapeutics Inc (NASDAQ: OTLK) shares are slumping after the company announced that it has completed the requested Type A Meetings with the FDA to discuss the Complete Response Letter (CRL).
The company received the letter in August regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat Wet Age-Related Macular Degeneration (Wet AMD).
The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the ...