Bitcoin pioneer Charlie Shrem peels back the layers on the lives and backgrounds of the world's most impactful innovators. Centering around intimate narratives, Shrem uncovers a detailed, previously unspoken story of the genesis and evolution of bitcoin, cryptocurrency, artificial intelligence, and the web3 movements. Join Shrem as he journeys through the uncharted territories of tech revolutions, revealing the human side of the stories that shaped the digital world we live in today.
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Race Oncology receives US FDA rare paediatric disease designation for AML treatment
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Manage episode 424159738 series 2891889
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Race Oncology Ltd (ASX:RAC) executive director Peter Smith sits down with Proactive’s Meagan Evans to discuss the US Food and Drug Administration’s extension of its Rare Paediatric Disease Designation (RPDD) to RC220 bisantrene for the treatment of childhood (paediatric) subtypes of AML. The RPDD was previously granted to RC110 bisantrene in 2018. This designation is given to new treatments for serious or life-threatening diseases affecting fewer than 200,000 people in the US, primarily those under 18. Some 70% of rare diseases begin in childhood, with 95% lacking approved treatments. The RPDD allows sponsors to qualify for a Priority Review Voucher (PRV) from the US FDA upon marketing approval, enabling a six-month accelerated review of the drug. PRVs can be sold or transferred, with recent sales averaging more than US$100 million. Race Oncology is in discussions with Associate Professor Dr Himalee Sabnis from Emory University and an international paediatric oncology cooperative group to explore trials of RC220 bisantrene as a salvage treatment for paediatric AML. Although no agreements have been finalized, the interest from leading paediatric oncologists is promising. #ProactiveInvestors #RaceOncology #ASX #USFDA #RC220 #bisantrene #RPDD #AML #PriorityReviewVoucher #Biotech #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
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605 episodes
MP3•Episode home
Manage episode 424159738 series 2891889
Content provided by Proactive Investors. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Proactive Investors or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
Race Oncology Ltd (ASX:RAC) executive director Peter Smith sits down with Proactive’s Meagan Evans to discuss the US Food and Drug Administration’s extension of its Rare Paediatric Disease Designation (RPDD) to RC220 bisantrene for the treatment of childhood (paediatric) subtypes of AML. The RPDD was previously granted to RC110 bisantrene in 2018. This designation is given to new treatments for serious or life-threatening diseases affecting fewer than 200,000 people in the US, primarily those under 18. Some 70% of rare diseases begin in childhood, with 95% lacking approved treatments. The RPDD allows sponsors to qualify for a Priority Review Voucher (PRV) from the US FDA upon marketing approval, enabling a six-month accelerated review of the drug. PRVs can be sold or transferred, with recent sales averaging more than US$100 million. Race Oncology is in discussions with Associate Professor Dr Himalee Sabnis from Emory University and an international paediatric oncology cooperative group to explore trials of RC220 bisantrene as a salvage treatment for paediatric AML. Although no agreements have been finalized, the interest from leading paediatric oncologists is promising. #ProactiveInvestors #RaceOncology #ASX #USFDA #RC220 #bisantrene #RPDD #AML #PriorityReviewVoucher #Biotech #invest #investing #investment #investor #stockmarket #stocks #stock #stockmarketnews
…
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