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Oral tolerance

Glycemic improvements typically become apparent within 4 weeks of reaching therapeutic doses (5 mg or higher), with maximal HbA1c reduction at 12-24 weeks

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Supply via a 'specials' or named-patient route is not a routine or straightforward pathway for a new investigational agent of this kind and would require robust regulatory justification

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Questions still remain The FDA meeting is unlikely to settle the broader debate around peptides