@simons77 and @FreeFromStyle:
OPT-302 is planned to be filed with primary efficacy data at week 52.
Submission for approval will NOT include 2y extended safety data.
Please check history with Roche and farizimab/Vabysmo, the most recent approval in the world of wAMD:
Submission was done with the 40/44/48 week efficacy data and did NOT include the 112 week extended safety data that was still ongoing at the time.
There is on reason to assume OPT‘s filing process to be different from ROG.
That makes the following time line the most probable:
April/May 2024: 2nd P3 ShORe fully enrolled
May/June 2025: Topline data (52 week efficacy)
Aug/Sep 2025: Filing for approval
2Q 2026: Approval
Of course, the obvious need for financing down this path has to be met by management. And time is ticking increasingly hard with cash left for 6 months only…
Yet, my feeling is the longer the game lasts the higher the probability of a regional partnership becomes.
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