Outlook Therapeutics Inc (OTLK)

[H2R]

OTLK Consistent Timelines

The PR's show the planning and then the adjustments to the planning. Compared to other biotechs in clinical trial stages, I find them refreshingly consistent.


From March 31st:

Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021, followed by BLA submission by end of 2021

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-safety-profile-norse-three


From August 3rd:

Full data from NORSE TWO will be presented at an ophthalmology conference in the fall of 2021 and submitted for publication in a peer-reviewed journal.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-efficacy-and-safety-data



From September 28th:

Outlook Therapeutics Reports New Positive 12-Month Safety Data from Pivotal Phase 3 NORSE TWO Trial

Full data to be presented at American Academy of Ophthalmology’s Retina Subspecialty Meeting, RET13 - Section X: Late Breaking Developments, Part II on November 13th at 9:17 AM ET

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-new-positive-12-month-safety-data



So I would tend to trust the planning expressed in the latest corporate presentation, dated October 2021:

Compelling pivotal data supports
U.S. FDA BLA submission,
targeted for calendar Q1 2022

https://ir.outlooktherapeutics.com/static-files/70f2afe2-b97b-4e79-8067-64d05f977e77 , page 4


Best of luck with your investments!