August 13, 2024, FDA - Freedom of Information Act Request submitted and acknowledged by the FDA. The response time is 20 working days with an additional 10 days if needed. This places a response from the FDA between September 11, 2024 and September 25, 2024.
FOIA requested:
Information between the months of October 2023 and August 2024
(1) The company Biologics License Application (BLA) number for 131 I-Apamistamab (Iomab-B)
(2) Historical timeline of events correlated with the BLA number for 131 I-Apamistamab (Iomab-B)
(2) Verification of receipt/acknowledgement of a BLA for 131 I-Apamistamab (Iomab-B) between January 2024 and August 2024.
(3) Complete response letter/opinion/proceedings for 131I-Apamistamab (Iomab-B) where the "FDA determined that the Phase 3
SIERRA trial is not adequate to support a BLA filing for Iomab-B" according to the company press release made on August 5, 2024.
(4) Dates and meeting minutes of Chemistry, Manufacturing and Controls (“CMC”) interactions with the FDA and company
(5) Dates and meeting minutes of Clinical/Non-Clinical interactions with the FDA and company

August 18, 2024, Request for support of this petition submitted to AML-Hub.com, MSKCC, and Fred Hutch Cancer Center.