Bitcoin groundbreakers share personal stories of how Bitcoin is changing lives for the better. Host Mauricio Di Bartolomeo, co-founder and CSO of Ledn, speaks with leading Bitcoin voices, entrepreneurs, and human rights advocates to hear their unique journey and practical real-world examples of how Bitcoin has made a positive impact in their lives. Brought to you by Ledn, a leading financial services company built for Bitcoin & digital assets. Ledn offers a suite of lending, saving and tradi ...
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Tonix Pharmaceuticals gets FDA Fast Track designation for fibromyalgia therapy
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Manage episode 432845498 series 2891889
Conteúdo fornecido por Proactive Investors. Todo o conteúdo do podcast, incluindo episódios, gráficos e descrições de podcast, é carregado e fornecido diretamente por Proactive Investors ou por seu parceiro de plataforma de podcast. Se você acredita que alguém está usando seu trabalho protegido por direitos autorais sem sua permissão, siga o processo descrito aqui https://pt.player.fm/legal.
Tonix Pharmaceuticals CEO Seth Lederman joins Proactive's Stephen Gunnion after the company received FDA Fast Track designation for its drug candidate, TNX-102, aimed at managing fibromyalgia. Lederman expressed delight at the FDA's recognition of TNX-102, highlighting that this designation will expedite interactions with the FDA as they seek marketing approval, expected in 2025. He explained that fibromyalgia is a serious chronic pain condition affecting mostly women, with about 10 million patients in the United States alone. Discussing the market opportunity, Lederman mentioned that over 2 million people are currently diagnosed and treated for fibromyalgia, indicating a significant market potential. TNX 102 stands out in the market due to its impact on pain, sleep, and fatigue, with fewer side effects compared to existing treatments. Recent trials showed statistically significant improvements in these areas, positioning TNX 102 as a promising treatment. Tonix Pharmaceuticals is preparing a new drug application, aiming for a submission in the second half of 2024 and anticipating FDA approval in 2025. The Fast Track designation may also lead to a priority review, potentially reducing the review time to six months. For more updates and detailed insights, visit Proactive's YouTube channel, give the video a like, subscribe to the channel, and enable notifications for future content. #TonixPharmaceuticals #FibromyalgiaTreatment #TNX-102 #FDAFastTrack #ChronicPain #PharmaNews #MedicalResearch #DrugApproval #HealthcareInnovation #ProactiveInterviews #ProactiveInvestors #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
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607 episódios
MP3•Home de episódios
Manage episode 432845498 series 2891889
Conteúdo fornecido por Proactive Investors. Todo o conteúdo do podcast, incluindo episódios, gráficos e descrições de podcast, é carregado e fornecido diretamente por Proactive Investors ou por seu parceiro de plataforma de podcast. Se você acredita que alguém está usando seu trabalho protegido por direitos autorais sem sua permissão, siga o processo descrito aqui https://pt.player.fm/legal.
Tonix Pharmaceuticals CEO Seth Lederman joins Proactive's Stephen Gunnion after the company received FDA Fast Track designation for its drug candidate, TNX-102, aimed at managing fibromyalgia. Lederman expressed delight at the FDA's recognition of TNX-102, highlighting that this designation will expedite interactions with the FDA as they seek marketing approval, expected in 2025. He explained that fibromyalgia is a serious chronic pain condition affecting mostly women, with about 10 million patients in the United States alone. Discussing the market opportunity, Lederman mentioned that over 2 million people are currently diagnosed and treated for fibromyalgia, indicating a significant market potential. TNX 102 stands out in the market due to its impact on pain, sleep, and fatigue, with fewer side effects compared to existing treatments. Recent trials showed statistically significant improvements in these areas, positioning TNX 102 as a promising treatment. Tonix Pharmaceuticals is preparing a new drug application, aiming for a submission in the second half of 2024 and anticipating FDA approval in 2025. The Fast Track designation may also lead to a priority review, potentially reducing the review time to six months. For more updates and detailed insights, visit Proactive's YouTube channel, give the video a like, subscribe to the channel, and enable notifications for future content. #TonixPharmaceuticals #FibromyalgiaTreatment #TNX-102 #FDAFastTrack #ChronicPain #PharmaNews #MedicalResearch #DrugApproval #HealthcareInnovation #ProactiveInterviews #ProactiveInvestors #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
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