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Re: FeMike post# 766201

Tuesday, 05/06/2025 1:53:12 PM

Tuesday, May 06, 2025 1:53:12 PM

Post# of 774787

but I am getting more and more worried it may be the best explanation for the current situation.


thats is NOT what is going on. Dont be shy and reply.

This is what is going on. Timeline review
June 27, 2024 — First CHM review (likely advisory stage; CHM gives initial recommendation to MHRA).
July–August 2024 — MHRA issues first RFI (Request for Information); "clock stops" during this period while NWBO prepares answers.
September–November 2024 — NWBO submits RFI answers; "clock resumes", likely for a 60-day evaluation period, bringing us to ~Nov 1, 2024.
October 2024 – February 2025 — MHRA conducts GCP (Good Clinical Practice) inspections at clinical trial sites. These inspections can run in parallel with ongoing review.
End of March 2025 — Second RFI issued, likely based on inspection findings.
April–May 2025 (We are here) — NWBO responds to second RFI; clock is again off during this response phase.
June–July 2025 — MHRA processes the second RFI responses; clock resumes. Based on historical timelines, this puts a final decision around mid-July 2025.
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