05 · REVW · SENTINEL · WORKBENCH
Authority review · RFI queue
1 of 240 RFIs sealed · PMDA 120-day clock running
Agent reasoning trace · SENTINEL
PMDA RFI #14 received · indication scope queryyudh…1401
15 May 22:40 JSTIndication narrowing accepted · CRO sign-offyudh…1418
16 May 14:20 JSTRFI #14 response sealed · label v3 locked091d…4f8a
16 May 22:08 JSTRFI queue · 240 total
1 / 240 sealed · 4.2-day avg response
#14 PMDASEALED · indication narrowed
#15–#48 PMDAin flight
HSA reliance Q&Aqueued · gated on PMDA
KFDA day 28/72on track
Q&A drafter
AVG RESPONSE4.2 days
DRAFTS IN PROGRESS34 (PMDA batch)
HUMAN GATECRO sign-off on scope changes
Review windows
PMDA120 days · clock from 18 May 09:00 JST
HSAReliance · post-PMDA milestone
KFDAIndependent · day 28 of 72
Governance
Receipt chain
RFI #14 sealed091d…4f8a
Human sign-offs
Sarah Chen · RFI #14 accept16 May · ✓
Framework parity
PMDAHSAKFDAPOL-LABEL-NARROWING-V1POL-RA-COUNCIL-V1