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What completing formal drug development gives you is much more information This information allows you to make evidence-informed decisions It tells you that the actual drug has been shown to produce a defined benefit in a defined human population It gives you a study dose, a formulation, a route of administration and a pharmacokinetic profile It gives you a characterized safety profile, known contraindications, known drug interactions, and monitoring requirements It also gives you manufacturing standards around identity, potency, purity, stability, sterility, and lot-to-lot consistency It’s a lot of stuff here With approved drugs, those questions are at least formally addressed Peter emphasizes, “ With many non-approved peptides, [these questions] they are virtually all unanswered

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