From ChatGTP
Alright — let’s walk through Scenario 1: CHM end-June ? new questions ? another RFI and work out the realistic and outer-limit decision windows.
Knowns & Assumptions
CHM meeting: 26–27 June 2025
New questions issued: Let’s assume MHRA formulated the RFI within ~7–14 days after CHM (by ~5–10 July).
RFI response time allowed:
MHRA guidance: up to 90 calendar days for a sponsor to respond to an RFI.
NWBO historically uses long response windows (especially for final RFI rounds).
Transition period: MHRA guidance adds ~3 days admin time after a response before the next clock-on.
Final MHRA review after last RFI: Typically ~30–40 days clock-on for final assessment and decision.
Timeline calculation (outer limit)
Step Date Range
RFI issued ~5–10 July 2025
NWBO takes full 90 days to ~3–8 October 2025
+3 days transition to ~6–11 October 2025
Final MHRA clock-on (30–40 days) to ~5–20 November 2025
Decision notification to NWBO ~5–20 November 2025
Public announcement 1–5 business days later
Outer limit: Mid-to-late November 2025 for public disclosure if they use every day available.
More likely if NWBO responds faster
If NWBO responds in, say, 60 days instead of 90:
RFI response due: early September
MHRA final review complete: early-to-mid October
Public disclosure: October 2025
Conclusion
Fastest plausible: early October 2025 announcement
Slowest plausible: mid-to-late November 2025 announcement
Given NWBO’s historic pace, late October. Early November feels most realistic if we’re indeed in the “third RFI” phase now.
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