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DTSTART;TZID=America/New_York:20250918T150000
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SUMMARY:Community Webinar with Saol Therapeutics to Discuss SL1009 (DCA)
DESCRIPTION:Register Here Community Webinar with Saol Therapeutics to Discuss SL1009 (DCA)\nThursday\, September 18\, 3:00 PM – 4:00 PM EDT  \nLast week\, Saol Therapeutics shared the FDA has issued a Complete Response Letter (CRL) regarding the company’s application for dichloroacetate (DCA) to treat Pyruvate Dehydrogenase Complex Deficiency (PDCD). In this CRL\, the FDA declined to approve DCA at this time and requested that Saol initiate a new clinical trial to address remaining questions. Here you will find a community statement from Saol. \nWe are deeply disappointed by this outcome and mindful of what it means for families awaiting options. Our collective organizations remain committed to advocating for timely\, patient-centered next steps\, engaging with regulators\, and keeping you informed as more details emerge. You can read our full statement here. \nAs part of that commitment\, you’re invited to a special webinar on Thursday\, September 18\, at 3pm EDT\, where you can submit questions and hear directly from Saol leadership regarding DCA\, the clinical trial\, and the path forward with the FDA. Any questions you would like to ask can be submitted on the registration page. \nHost:\nFrances Pimentel\, Hope for PDCD \nFeatured speakers include:\nDave Penake\, CEO\, Saol Therapeutics\nKyle Ashton\, PhD\, Head of Medical Affairs\, Saol Therapeutics\nSharon Hamm\, Pharm.D.\, RPH\, Chief Development Officer\, Saol Therapeutics\nBrian Nappi\, Chief Strategy Officer\, Saol Therapeutics
URL:https://umdf.org/event/community-webinar-with-saol-therapeutics-to-discuss-sl1009-dca/
CATEGORIES:Clinical Trials,Education
ORGANIZER;CN="Kara Strittmatter":MAILTO:kara@umdf.org
LOCATION:https://umdf.org/event/community-webinar-with-saol-therapeutics-to-discuss-sl1009-dca/
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