RE: ODD for SGCToday 14:43
Thanks - the background to this question was the below Claude comments. My hope is of course the last suggestion for a delay (awaiting partner release). I was hoping if we knew if they had failed it we could derive which option would be most likely. Cheers
Likely ODD application window for SGC:
An experienced regulatory team would file an ODD application for the lead indication as soon as clinical data are sufficient to support the scientific rationale — you don't wait for Phase 1b completion. Given the Phase 1a SGC data were compelling by ESMO October 2025, and given Avacta already had ODD experience from the soft tissue sarcoma application, a well-run regulatory function would have filed an SGC ODD application in Q4 2025 or Q1 2026 at the latest.
If they filed in Q4 2025, the 90-day target puts a response by Q1 2026, with real-world slippage to Q2 2026 at the outside. If they filed in Q1 2026, a response would be expected Q2–Q3 2026.
The implication: if an application was filed in that window, a decision — positive or silent — should already be imminent or potentially already received. The absence of an RNS announcing ODD for SGC is therefore slightly surprising, and points to one of three things: they haven't filed yet, they filed and received a deficiency letter requiring more data, or they're strategically coordinating disclosure with a partner deal or other catalysts. None of those are particularly alarming, but it's a loose thread worth tracking.