I have lived with Duchenne muscular dystrophy for 27 years, and I am not about to stop now.

On August 22, 2026, the FDA will decide whether to approve deramiocel, a cell therapy for Duchenne-associated cardiomyopathy. It’s also shown positive benefits for upper limb functioning. For me, this decision is the difference between a future and no future at all.

Cardiomyopathy is the leading cause of death for people with Duchenne. Nearly every one of us develops it. There is no FDA-approved therapy that treats it. Cardiac care today is supportive and we manage the decline. None of that is in dispute by anyone.

Deramiocel is a drug that can help me continue on my mission to change the world by preserving my heart function. Protecting my heart will give me the opportunity to marry the love of my life, raise the family I deserve, and become the entrepreneur and philanthropist this world needs. These are things that would be impossible without modern medicine.

On July 29, an FDA advisory committee voted 9-3 that the evidence did not establish effectiveness, despite evidence confirming benefit in the HOPE-3 study. I am not going to tell you the statistics are simple, because they are not. The FDA and Capricor disagree about which statistical analysis plan governs the HOPE-3 results, and therefore about what the trial showed. I cannot settle that argument, and neither can the people signing this petition. 

Many things are not in dispute:

1. Real people like you and me have reported quality of life improvements and physical benefits from deramiocel, some of which are difficult to detect in trials. We can’t disregard the patient experience and rip these benefits away from children and adults.
2. There is nothing else. No approved therapy alters the course of Duchenne cardiomyopathy. My previous attempts to access deramiocel under Right to Try were denied. My cardiologist recently said that he always thinks of me because I never take no for an answer. As much as it pains me to say this, another denial is very likely my last hurrah.
3. Deramiocel is safe. In HOPE-3, six serious adverse events occurred: five in the placebo arm, one on deramiocel. No deaths or decompensation. Hypersensitivity reactions are real, and are effectively managed with premedication and administration at an infusion center. I will accept that risk, and I should be allowed to.
4. The cost of being wrong is not symmetric. Heart muscle that dies does not come back. If the FDA approves and the benefit turns out smaller than hoped, patients will have received a therapy whose serious adverse event rate was lower than placebo while more data accumulated. If the FDA denies and the benefit was real, a generation of us loses cardiac function that no later approval can give back. Those two mistakes are not equivalent, and a decision made under uncertainty should account for that.

Here is what I am asking for. Approve deramiocel. And if the dispute over the analysis plan truly cannot be resolved by August 22, FDA should approve a narrower label covering the patients with Duchenne cardiomyopathy, with post-marketing requirements and registry follow-up attached. Alternatively, as a last resort, extend the review by 30 days and resolve the dispute rather than issuing a denial. An extension costs weeks, but a denial costs years that we do not have. Those tools exist for regulatory flexibility. Please use them.

To the FDA, Secretary Kennedy, and President Trump: you have spoken about putting patients first and using regulatory flexibility for rare disease. This is what that looks like in practice, on a real deadline, for real people. I am one of them.

Sign this petition to tell the FDA, HHS, and the White House: make yes the answer.

Thank you for your dedication to the American people, and thank you for reading my story.

Jacob Hill