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Eli Lillys explanation about who it will consider for expanded access broadly follows the widely held understanding of the term, including the stipulation that eligible patients must have a serious or life-threatening illness with no comparable or satisfactory alternative therapies. Thats partly why the decision to grant expanded access for a medication primarily known for weight loss raised so many questions

Up to 55% of patients developed anti-drug antibodies [65], which were associated with systemic allergic reactions in approximately 5% of cases and injection-site hypersensitivity, including anaphylaxis, which necessitated early trial termination [66, 67]

The safety profiles are similarly favourable

It reflects what the pharmacokinetic data shows about receptor adaptation and tolerability windows