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There is no Therapeutic Use Exemption pathway for an unapproved substance

Robert Kushner: I haven't seen that paper, but what I can say which I thought you were getting to is that when we look at the categorical weight loss in all these trials, so some people lose 5%, 10%, 20%, 25% over the course of the trial, if you then stop the medication, the individuals who lost the greatest amount of body weight actually are the ones that regain it the quickest

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The regulatory reality: GLP-1s are FDA-approved medications