157: Expanded Access Crash Course with Ally Roets and Dr. Michelle Mellion
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157: Expanded Access Crash Course with Ally Roets and Dr. Michelle Mellion
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—what is Expanded Access; how it differs from Open Label Extension; and who can qualify for EA
—the application process and general timelines
—Familial, medical, and financial considerations including how to cover costs that insurance might deny or, at minimum, not cover
—the importance of increasing access to treatments and the benefits of expanded access.
This episode is packed with insight and worth repeat listens.
Ally Roets co-leads the month Parents’ Roundtable Gathering Place group and the Cure FSHD for All initiative. Ally is a passionate parent and advocate for access to treatments, and ultimately a cure, for everyone living with FSHD including those who fall outside trial inclusion criteria.
Dr. Michelle Mellion is the Chief Medical Officer for the FSHD Society and a clinician well-known for her work in the FSHD space. Dr. Mellion has worked both as a clinician and within the biotech/pharmaceutical spaces and is a passionate advocate for treatment access and the Early Onset community.
Please see the FDA website for more information on Expanded Access: https://www.fda.gov/news-events/public-health-focus/expanded-access
No one knows the experience of living with FSHD better than those who have it. FSHD Straight Talk features stories of life with this rare disease. Tune in to learn from, laugh, celebrate and sometimes grieve with fellow members of the FSHD community. Whatever your journey, we hope you’ll find yourself in these episodes and know you are not alone.
On the second and fourth Tuesday of every month, listen for a new episode of FSHD Straight Talk with Tim Hollenback! These episodes highlight members of the FSHD Community who are living rich, full lives and diving into their experiences with FSHD. If you would like to share your experiences living with FSHD, please reach out via email or send us a message on social media.
Email: FSHDRadio@FSHDSociety.Org
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