Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,
There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?
The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum
Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.
As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.
Recent OTLK News
- Outlook Therapeutics® to Participate in the Virtual Investor Closing Bell Series • GlobeNewswire Inc. • 09/16/2024 12:05:00 PM
- Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series • GlobeNewswire Inc. • 09/13/2024 01:05:00 PM
- Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial • GlobeNewswire Inc. • 09/04/2024 12:35:00 PM
- Outlook Therapeutics® to Present at the H.C. Wainwright 26th Annual Global Investment Conference • GlobeNewswire Inc. • 09/03/2024 12:45:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/14/2024 08:55:20 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:15:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:48:51 AM
- Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 08/14/2024 11:05:00 AM
- Outlook Therapeutics® to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference • GlobeNewswire Inc. • 08/12/2024 01:05:00 PM
- Outlook Therapeutics® to Report Financial Results for Third Quarter Fiscal Year 2024 on August 14, 2024 and Host Quarterly Conference Call and Webcast • GlobeNewswire Inc. • 08/07/2024 12:35:00 PM
- Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024 • GlobeNewswire Inc. • 07/30/2024 01:10:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 12:41:41 PM
- Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD • GlobeNewswire Inc. • 07/08/2024 12:35:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 06/14/2024 08:10:50 PM
- Outlook Therapeutics® to Present at the Virtual Investor Pitch Conference • GlobeNewswire Inc. • 06/11/2024 01:05:00 PM
- Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD • GlobeNewswire Inc. • 05/28/2024 12:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:19:05 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 09:15:37 PM
- Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 05/15/2024 09:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:05:33 PM
- Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD • GlobeNewswire Inc. • 05/13/2024 12:50:00 PM
- Outlook Therapeutics® to Report Financial Results for Second Quarter Fiscal Year 2024 on May 16, 2024 and Host Inaugural Quarterly Conference Call and Webcast • GlobeNewswire Inc. • 05/09/2024 12:45:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/07/2024 04:15:34 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 08:09:46 PM
- Outlook Therapeutics® to Present at the Retina World Congress 2024 • GlobeNewswire Inc. • 05/02/2024 01:05:00 PM
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