Outlook Therapeutics Inc (OTLK)

[H2R]

September resubmission confirmed

The Company issued a PR reiterating the September resubmission timeframe:

Outlook Therapeutics reiterates expected re-submission of BLA by September 2022 following receipt of additional correspondence from U.S. Food and Drug Administration (FDA)

ISELIN, N.J., June 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, is providing an update on its Biologics License Application (BLA) submission for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

As previously announced, Outlook Therapeutics submitted its BLA for ONS-5010 to the FDA in March 2022 and subsequently voluntarily withdrew its submission in May 2022 to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, Outlook Therapeutics has confirmed the additional information necessary to re-submit the BLA for ONS-5010.

C. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “The additional correspondence from the FDA confirms our commitment to our shareholders to re-submit a completed BLA to FDA by September of this year. As stated previously, we believe the results from our clinical trials demonstrated safety and efficacy and we are on-track to re-submit this BLA and, if approved, to deliver the first FDA-approved ophthalmic formulation of bevacizumab to the retina community.”

The good news with OTLK is that they take their timelines seriously, so I do expect the re-submission to happen according to their PR.

Best of luck with your investments!