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H2R

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Alias Born 07/17/2014

H2R

Re: None

Monday, 08/21/2023 4:37:20 PM

Monday, August 21, 2023 4:37:20 PM

Post# of 1489
Last lap before PDUFA decision. A few days left before, hopefully, approval, after the traditional long clinical trial marathons, a culmination of years of work.

Less than 10 calendar days. To put in perspective:

August 30, 2022, Resubmittal after CRL
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application

March 31, 2022 First submittal to the FDA
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us

August 3, 2021, top line data:
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-efficacy-and-safety-data

July 16, 2019 First Patient in the Second Phase 3
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-doses-first-patient-second-phase-3-clinical

October 5, 2015 Primary and Secondary Endpoints in Phase 1
https://ir.outlooktherapeutics.com/news-releases/news-release-details/ons-1045-avastinrbevacizumab-biosimilar-meets-primary-and

Investments in biotech is not for the faint of heart. We are about to get the news, it could be any time before the 29 too. I can wait :)

Best of luck with your investments!
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