Comment from Lori Mills

Commissioner’s National Priority Voucher (CNPV) Pilot Program Docket No. FDA-2026-N-2366 Public Hearing Comment Submitted by: Lori Mills Simi Valley, California Date: June 10, 2026 Dear FDA Docket Administrator, I submit this written testimony following my in-person testimony at the June 4, 2026, public hearing on the Commissioner’s National Priority Voucher (CNPV) Pilot Program. As a dedicated caregiver and patient advocate, I urge the FDA to leverage the CNPV framework and other accelerated approval pathways to rapidly expand access to life-saving immunotherapies such as ANKTIVA (N-803) and NK cell/IL-15-based therapies. Our Story On October 6, 2025, my husband of 27 years, Andrew Mills, collapsed at home. A CT scan revealed a large, aggressive brain mass. He underwent emergency craniotomy at Adventist Health Glendale and was diagnosed with glioblastoma multiforme (GBM) a terminal brain cancer with a typical prognosis of about 12 months. We were advised to prepare for hospice. His tumor exhibited molecular features associated with heightened aggressiveness and rapid progression. I refused to accept this death sentence. After learning of Dr. Patrick Soon-Shiong’s groundbreaking work with ANKTIVA (N-803) and natural killer (NK) cell therapy, I transferred Andrew’s care to Cedars-Sinai Medical Center in Los Angeles. I assembled a collaborative care team, coordinated directly with ImmunityBio, and navigated significant FDA barriers that required evidence of disease progression or failure of standard treatments before compassionate use could be considered. We eventually secured approval. Andrew received standard-of-care therapy combined with ANKTIVA (N-803) and started PDL-1-targeted NK cell therapy at Dr. Soon-Shiong’s clinic in El Segundo. This immune-boosting regimen protected his immune system and prevented the severe drop in Absolute Lymphocyte Count (ALC) that commonly accompanies standard care. Living Proof: Serial Brain MRI Evidence Attached are Andrew’s brain scan images (pre- and post-treatment series) for visual documentation: •Pre-Treatment Scan (October 6, 2025, Adventist Health Glendale): Large, aggressive mass with significant edema and mass effect. •Post-Treatment Scans (December 2025 – May 24, 2026, Cedars-Sinai Medical Center): All four post-treatment scans have been normal, no residual tumor, recurrence, swelling, or disease. Healthy brain tissue has fully filled the surgical cavity. Andrew’s Cedars-Sinai oncologist, Dr. Jethro Hu, was astonished. He had anticipated post-radiation swelling, a cavity, and eventual regrowth. Instead, Andrew experienced zero swelling and complete healing, with ALC rebound. Dr. Hu has expressed interest in offering this therapy but remains blocked by FDA restrictions. Barriers and the Urgent Need for CNPV-Style Acceleration This therapy is currently available only at one clinic in El Segundo, California. Dr. Soon-Shiong must turn away thousands of desperate patients daily due to capacity. Families face huge travel, logistics, and financial burdens, or denial of care. Patients in countries like Saudi Arabia and Austria can access ANKTIVA more easily than Americans. This is unacceptable. The ongoing 14+ year BCG shortage continues to devastate bladder cancer patients, even though ANKTIVA + BCG is already approved and highly effective for BCG-unresponsive non-muscle invasive bladder cancer. Recommendations for the CNPV Pilot and Broader Policy The CNPV Pilot Program should prioritize immunotherapies like ANKTIVA and NK/IL-15 therapies for ultra-fast review and expanded access. I specifically recommend: •Streamlining and expanding Expanded Access and Right to Try programs for these therapies. •Utilizing CNPV and Priority Review Vouchers to accelerate approvals across multiple cancer types. •Removing the “fail standard treatments first” requirement for terminal and aggressive cancers. •Incorporating real-world evidence, serial scans, and treating physician testimony into decision-making. •Support nationwide infrastructure development, including cryopreservation, manufacturing scale-up, and physician training. •Prioritizing early intervention of therapy for patients and address BCG shortages for bladder cancer patients. •Ensure transparency and prevent suppression of scientific communication around these therapies. Andrew’s recovery documented by scans and sustained health post-treatment proves what timely access can achieve. No family should have to fight the battles we did. Families deserve time and hope I am happy to provide full medical records (with proper authorization), additional scans, blood work, and facilitate direct contact with Andrew’s Cedars-Sinai team and ImmunityBio. Thank you for considering this testimony and for the CNPV Pilot Program’s focus on national priorities. I urge swift action to make these transformative therapies available nationwide without delay. Sincerely, Lori Mills