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Heads up, the pharmaceutical world is watching this one closely! If this drug secures approval, its market position suggests serious success. However, keep an eye out for any potential PDUFA timeline hiccups—that’s the wildcard! The technical side is fascinating: the NDA is utilizing the 505(b)(2) pathway, which demands solid pharmacokinetic and pharmacodynamic comparability data against existing intramuscular epinephrine formulations. That bridge is crucial! 💉📈 #DrugDevelopment #PharmaNews #F
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