Monday, August 21, 2023 4:37:20 PM
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!
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!
Bullish
Recent OTLK News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/26/2026 11:15:41 AM
- Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg) • GlobeNewswire Inc. • 05/26/2026 11:00:00 AM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 05/22/2026 09:03:14 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2026 08:31:12 PM
- Outlook Therapeutics Reports Second Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update • GlobeNewswire Inc. • 05/15/2026 08:05:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 05/13/2026 09:12:56 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2026 08:36:26 PM
- Form D - Notice of Exempt Offering of Securities • Edgar (US Regulatory) • 05/07/2026 08:24:31 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/23/2026 08:30:39 PM
- Outlook Therapeutics Announces Closing of $5.0 Million Registered Direct Offering • GlobeNewswire Inc. • 04/23/2026 08:05:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 04/23/2026 11:30:17 AM
- Outlook Therapeutics Announces $5.0 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules • GlobeNewswire Inc. • 04/22/2026 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/21/2026 08:15:44 PM
- Outlook Therapeutics Completes Federal Dispute Resolution (FDR) Meeting with FDA for ONS-5010/LYTENAVA™ (bevacizumab-vikg) • GlobeNewswire Inc. • 04/21/2026 01:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 04/07/2026 08:15:24 PM
- Outlook Therapeutics Announces Formal Dispute Resolution Request for ONS-5010/LYTENAVA™ (bevacizumab-vikg) Accepted by FDA • GlobeNewswire Inc. • 04/07/2026 12:50:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/25/2026 09:04:56 PM
- Outlook Therapeutics Announces Closing of $5.0 Million Public Offering • GlobeNewswire Inc. • 03/25/2026 08:05:00 PM
- Outlook Therapeutics Announces Pricing of $5.0 Million Public Offering • GlobeNewswire Inc. • 03/24/2026 11:00:00 AM
- Outlook Therapeutics Announces Proposed Public Offering • GlobeNewswire Inc. • 03/23/2026 09:30:00 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 03/23/2026 09:18:35 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/16/2026 01:00:28 PM
- Outlook Therapeutics Announces New $18.4 Million Non-Convertible Note Financing and Amendment to Existing Convertible Note • GlobeNewswire Inc. • 03/16/2026 12:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/10/2026 08:30:54 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/05/2026 10:01:18 PM
