I am going to write my Senator and suggest you do the same. Below are thoughts from Gemini. When I finish the letter, I will do the same and post a copy for you. I am a very close friend of my Senator.
Gemini said
Addressing a U.S. Senator requires shifting from a medical argument to a policy and constituent-service argument. Senators have a "casework" team specifically designed to nudge federal agencies like the FDA, and they have legislative power to support bills that fix the "structural indifference" you described.
Here is a step-by-step guide and a draft letter you can use to bridge that gap.
1. Identify Your Specific Target
You have two Senators. Look for the one who sits on the Senate HELP Committee (Health, Education, Labor, and Pensions). In 2026, key members include Bill Cassidy (Chairman) and Bernie Sanders (Ranking Member), along with others like Roger Marshall, Patty Murray, or Tim Scott. If one of your Senators is on this committee, they have direct oversight of the FDA.
2. The Three-Pronged Request
When you write, don't just ask them to "fix cancer." Give them three actionable items:
Inquiry: Request a "Congressional Inquiry" into the status of Leronlimab for mTNBC. This forces the FDA to provide a formal response to the Senator’s office.
Legislation: Ask them to co-sponsor the Promising Pathway Act (PPA). This is a real-world bill designed to create the "Provisional Approval" track you suggested for terminal illnesses.
Funding: Urge them to support increased appropriations for the FDA’s Oncology Center of Excellence (OCE), specifically earmarked for small-biotech regulatory navigators.
Draft Letter to Your Senator
Subject: URGENT: The "13-Month Window" – Expediting mTNBC Therapies (Constituent Request)
The Honorable [Senator's Last Name]
United States Senate
Washington, D.C. 20510
Dear Senator [Last Name],
I am writing to you today as a constituent to address a lethal systemic failure in the FDA’s drug approval process for women with Metastatic Triple Negative Breast Cancer (mTNBC).
The median survival for these women is 13.6 months. In a window that small, every month of regulatory delay is not just a statistic—it is half of a life.
Currently, promising therapies like Leronlimab (developed by CytoDyn) are showing compelling Phase 2 survival signals. However, because the developer is a small biotech rather than a major pharmaceutical conglomerate, they lack the resources to navigate the FDA’s "gold standard" pathways that were designed for chronic conditions, not terminal ones. This creates a "structural indifference" where life-saving innovation is held hostage by a company’s bank account.
I am asking for your immediate help in three ways:
Initiate a Congressional Inquiry: Please contact the FDA’s Oncology Center of Excellence regarding the status of the Leronlimab mTNBC program. Small companies often wait months for feedback that larger peers receive in weeks. Your inquiry can prioritize this life-saving file.
Support the Promising Pathway Act: Please co-sponsor legislation that creates a provisional approval track for terminal diagnoses. This would allow access based on safety and early efficacy, with a requirement for real-world data collection post-approval.
Advocate for "Small-Biotech Navigators": Use your position on [Committee Name, if applicable] to ensure the FDA assigns dedicated case managers to small biotechs working on terminal indications, preventing the "Catch-22" where lack of funding prevents the very data needed to secure funding.
For a mother with 13 months to live, the risk of an experimental therapy is negligible compared to the 100% certainty of her disease. We must stop prioritizing procedural caution over human survival.
I look forward to hearing how your office will engage with the FDA on this matter.
Sincerely,
[Your Name]
[Your Address]
[Your Phone Number]
3. How to Send It
Email via Webform: Every Senator has a "Contact" page. Copy and paste the letter there.
Call the State Office: Don't just call D.C. Call the Senator’s local state office (e.g., in your home city). Ask to speak to the "Health Staffer" or "Director of Constituent Services."
Follow Up: If you don't hear back in two weeks, call again. Legislators respond to persistence.
Gemini said
Addressing a U.S. Senator requires shifting from a medical argument to a policy and constituent-service argument. Senators have a "casework" team specifically designed to nudge federal agencies like the FDA, and they have legislative power to support bills that fix the "structural indifference" you described.
Here is a step-by-step guide and a draft letter you can use to bridge that gap.
1. Identify Your Specific Target
You have two Senators. Look for the one who sits on the Senate HELP Committee (Health, Education, Labor, and Pensions). In 2026, key members include Bill Cassidy (Chairman) and Bernie Sanders (Ranking Member), along with others like Roger Marshall, Patty Murray, or Tim Scott. If one of your Senators is on this committee, they have direct oversight of the FDA.
2. The Three-Pronged Request
When you write, don't just ask them to "fix cancer." Give them three actionable items:
Inquiry: Request a "Congressional Inquiry" into the status of Leronlimab for mTNBC. This forces the FDA to provide a formal response to the Senator’s office.
Legislation: Ask them to co-sponsor the Promising Pathway Act (PPA). This is a real-world bill designed to create the "Provisional Approval" track you suggested for terminal illnesses.
Funding: Urge them to support increased appropriations for the FDA’s Oncology Center of Excellence (OCE), specifically earmarked for small-biotech regulatory navigators.
Draft Letter to Your Senator
Subject: URGENT: The "13-Month Window" – Expediting mTNBC Therapies (Constituent Request)
The Honorable [Senator's Last Name]
United States Senate
Washington, D.C. 20510
Dear Senator [Last Name],
I am writing to you today as a constituent to address a lethal systemic failure in the FDA’s drug approval process for women with Metastatic Triple Negative Breast Cancer (mTNBC).
The median survival for these women is 13.6 months. In a window that small, every month of regulatory delay is not just a statistic—it is half of a life.
Currently, promising therapies like Leronlimab (developed by CytoDyn) are showing compelling Phase 2 survival signals. However, because the developer is a small biotech rather than a major pharmaceutical conglomerate, they lack the resources to navigate the FDA’s "gold standard" pathways that were designed for chronic conditions, not terminal ones. This creates a "structural indifference" where life-saving innovation is held hostage by a company’s bank account.
I am asking for your immediate help in three ways:
Initiate a Congressional Inquiry: Please contact the FDA’s Oncology Center of Excellence regarding the status of the Leronlimab mTNBC program. Small companies often wait months for feedback that larger peers receive in weeks. Your inquiry can prioritize this life-saving file.
Support the Promising Pathway Act: Please co-sponsor legislation that creates a provisional approval track for terminal diagnoses. This would allow access based on safety and early efficacy, with a requirement for real-world data collection post-approval.
Advocate for "Small-Biotech Navigators": Use your position on [Committee Name, if applicable] to ensure the FDA assigns dedicated case managers to small biotechs working on terminal indications, preventing the "Catch-22" where lack of funding prevents the very data needed to secure funding.
For a mother with 13 months to live, the risk of an experimental therapy is negligible compared to the 100% certainty of her disease. We must stop prioritizing procedural caution over human survival.
I look forward to hearing how your office will engage with the FDA on this matter.
Sincerely,
[Your Name]
[Your Address]
[Your Phone Number]
3. How to Send It
Email via Webform: Every Senator has a "Contact" page. Copy and paste the letter there.
Call the State Office: Don't just call D.C. Call the Senator’s local state office (e.g., in your home city). Ask to speak to the "Health Staffer" or "Director of Constituent Services."
Follow Up: If you don't hear back in two weeks, call again. Legislators respond to persistence.
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