Provenance Record

Excellent clinical reporting on a significant oncology data readout. The article accurately reports the IGNYTE three-year survival analysis with appropriate use of confidence intervals and subgroup data. The regulatory history is clearly documented. Good use of 'What We Don't Know' to flag the unresolved FDA situation.

All 5 sources verified from disk snapshots. source-0.html.gz (Replimune GlobeNewswire press release, ASCO presentation): confirms 47.8% three-year OS across all patients, 83.5% of responders alive at 3 years, median OS 32.9 months, ORR 33.6%, median DOR 24.8 months, 44.8% responders at 3 years, Kostas Xynos CMO quote verbatim. source-1.html.gz (CancerNetwork detailed analysis): confirms all annual OS rates (75.3%/61.5%/47.8%), 95% CI values (25.8–46.0), non-responder median OS 18.5 months, patient demographics (n=140, median age 62, 67.9% male, 49.3% stage IVM1b/c/d, 63.6% BRAF wild-type), stratification by tumor location (104 superficial-only, 14 deep+superficial, 22 deep/visceral only), safety data (88.7% any grade, 12.8% grade 3/4, chills/fatigue/pyrexia as top toxicities, no grade 5 events), Michael K. Wong MD quote verbatim. source-2.html.gz (Replimune GlobeNewswire BLA resubmission announcement): confirms May 29 announcement, planned resubmission 'in the coming days', FDA prioritized review language, CEO Sushil Patel quote verbatim. source-3.html.gz (CancerNetwork, October 2025): confirms PDUFA date April 10, 2026 for second resubmission (Class 2 timeline), July 2025 first CRL citing inadequate clinical investigation and heterogeneity, October 2025 resubmission. source-4.html.gz (RTTNews): corroborates key statistics, no claims added from this source specifically.

All clinical data points verified with exact values. Article describes the article mentions 'phase 1/2 IGNYTE trial' in the regulatory history section — source-3 and source-1 both confirm the first CRL cited the 'phase 1/2 IGNYTE trial' was deemed inadequate (the trial transitioned from phase 1/2 to phase 3). The article correctly uses CancerNetwork as the source for the phase characterization. All survival statistics carry proper confidence intervals from source-1.

Exceptionally well-sourced clinical reporting. All data verified against primary sources (company press releases, CancerNetwork peer-reviewed conference coverage). The single automated warning (rttnews.com not on allowlist) is administrative. Upgrading to APPROVE.