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Time matters in a fight where 90 percent of patients die five years after diagnosis.
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Time matters in a fight where 90 percent of patients die five years after diagnosis. Collectively, the petitions included more than 20, signatures. The Honorable Ned Sharpless, M. There is no cure for ALS. Indeed, despite its words its actions display a true indifference to the plight of those living with ALS. The Draft Guidance document was released in February and the public comment period closed on April 21, In November , ten Members of Congress sent a letter asking about the Guidance.
Time and again the FDA either failed to respond or punted the deadline for publication. This is simply unacceptable. At a certain point, words, no matter how well-intentioned, become meaningless. So we write to request that you move past well-intentioned words and finally provide a firm date by which the Guidance will be released. We demand you make a commitment to publicly and regularly update us on the progress toward release, and an assurance that your staff will explain the ways you have incorporated our feedback and our lived experiences into the Guidance.
We focus on this document not because we enjoy writing letter after letter, but because it is critical to the fight against ALS.
Without it, we find ourselves handicapped by antiquated trial designs—designs that hinder the development of creative approaches to testing novel compounds and slow the development of critical, disease-altering therapeutics. We recognize the Guidance alone will not cure ALS, but it is an absolutely critical first step.
Our lives, and the lives of millions of others, depend on it. Kathie Hurst-Brown. Danut Tanasa. Sherri Youssef. Jenny Parks. Sandy Radley. Geoff Von Dollen. Pedro Carmo. Gloria Ferreira. Sigrid Rogers. Brent Collinson. Cody Verrett. David Franatovich. Tiffany Orihel. Gloria Green. Kelsey Whitaker. Grace Groody. Wade Chung. Jamie Perkins. Judith Gaw. Alaina Mclaughlin. Ariela Abrevaya. Kathy Wagner. Ariella Abuaf.
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Phone Numbers : [None]. Email Addresses : [None]. Associated Names : [None]. Family : Ashton Howell. Ashton Stonehowell. Azalia Cummings. Bethany Davis. Bethany Jeanne Davis. David J Cummings. Delina V Tschirhart. Desiree Marie Flowers. Frankie Rene Olvera. Gail F Cummings. Gary L Cummings.
Hattie M Montgomery. Heather Ellen Flowers. Jackalyn Rena Reed. Jeremy Daniel Howell JR. Joel Scott Davis. Jose G Davis. Joshua Don Howell. Joy S Stone. Karen J Davis. Karen S Davis. Kathryn Patricia Mcgee. Laurie L Stone. Linda Lee Montgomery. Luke H Cummings. Michael David Stone.
Michael R Stone. Michelle E Davis SR. Mike A Davis. Molly J Turnbow. Nancy Ann Howell. Nathanael L Cummings. Patricia Galo Davis. Paul A Davis.
Qusai Alqarqaz. Ryan Flowers. Ryan Thomas Flowers. Sam W Montgomery. Scott Davis. Sharon D Cummings. Staci L Charrette. Stacy L Davis. Tawas S Reed. Thomas D Turnbow. Thomas W Montgomery. Tony R Harris. Verlena C Cummings. Walter Edward Flowers. Wendy M Stone. Possible Associates : [None]. Businesses : [None]. Personal profile summary for Nathanael Cummings. Where does Nathanael Cummings currently live? What is the current phone number for Nathanael Cummings? What is the current email address for Nathanael Cummings?
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