Unfortunately, a double setback to the timeline.
First, page 8 of the aforementioned half year report:
“We expect to complete patient recruitment in the Phase 3 clinical trials by mid-2023.“
Accordingly, all milestones get pushed out by nine months:
- Full enrollment: mid-2023 (vs Sep 2022)
- Topline data: 3Q2024 (vs YE 2023)
- Filing: 1Q2025 (vs 2Q2024)
- Launch: 2H2025 (vs YE2024)
Second, OPT plans to incur higher than expected expenses by reverting to a CRO „to accelerate clinical trial activations and engagements with trial sites and investigators“, as mentioned in the same section of the report.
IMO, even the recently announced CR of $75 MN via an ATM should prove insufficient to make it to topline data in 3Q2024.
All in, a sobering update.
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