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PMID: 11368918

"This decision by CBER, which did not identify any safety or efficacy concerns with our product, does not further our shared goal of enhancing America's leadership in developing innovative medicines." - Stphane Bancel, chief executive officer of Moderna Moderna stated in its announcement that the RTF letter contradicts prior written guidance from CBER

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But like a lot of guys in this position, I started asking the next question