Outlook Therapeutics Inc (OTLK)

[H2R]

Upcoming Milestones

From today's PR:
http://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-provides-corporate-update-and-business

* Planned submission of new BLA to the FDA in the first calendar quarter of 2022;

* Execution of the NORSE SEVEN study evaluating Outlook Therapeutic’s vial delivery system versus a pre-filled syringe of ONS-5010;

* Ongoing pre-launch commercial planning underway in anticipation of potential ONS-5010 approval; and

*Continued progress on preparation for NORSE FOUR (BRVO) and NORSE FIVE AND SIX (DME) evaluating ONS-5010 for additional ophthalmic indications.

From another section of the PR:

If the BLA is approved as anticipated in the first quarter of calendar 2023, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

So their timeline for market approval is BLA Q1 2022, consistent with their planning over the last year and approval a year later. 9-12 months is not usual. When we see an actual PDFUA date set, this will become all the more real.

Best of luck with your investments!