While I very much wish whytee being right, I would not share his optimism regarding first trial results getting reported April 2025.
Reason being:
Eylea (aflibercept, REGN, BAY) reported topline data for two P3 trials VIEW1 and VIEW2 the same day on Nov 22, 2010 (2 months post primary completion date of the last trial having completed).
Beovu (brolucizumab, NOVN) reported topline data for two P3 trials HARRIER and HAWK the same day on Jun 20, 2017 (2 months post primary completion date of the last trial having completed)
Vabysmo (faricimab ROG) reported topline data for two P3 trials LUCERNE and TENAYA the same day on Jan 25, 2021 (3 months post primary completion date of the least trial having completed)
So personally, I doubt OPT will follow a different, that‘s a more aggressive pattern.
If I am right with COAST and ShORE reporting the same day, and if we further apply the above mentioned drug’s timeline to OPT-302, we can expect the following :
Best Case:
ShORe fully enrolled by May 2024
Primary completion date 52 weeks later = May 2025
Topline results for both COAST and ShORe2 months later = Jul 2025
Filing 4 months later (same as Vabysmo) = Nov 2025
Approval 8 months later (same as both Beovu and Vabysmo) = Jul 2026
Base Case (less good, but still completely in line with OPT‘s current guidance):
ShORe fully enrolled by Jun 2024
Primary completion date 52 weeks later = Jun 2025
Topline results for both COAST and ShORe3 months later = Sep 2025
Filing 4 months later (same as Vabysmo) = Jan 2026
Approval 8 months later (same as both Beovu and Vabysmo) = Sep 2026
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