Off label use is generally used by doctors for indications where there is no available treatment OR once all other treatments are exhausted ineffectively within the treatment guidelines.
If our phase 3 is successful, Exenatide will be integrated into the treatment guidelines as the first in class treatment for IIH as the only approved IIH drug/GLP-1 agonist for IIH.
Clients get diagnosed, this is the outlined approved drug in the treatment guideline, it is prescribed.
Currently there is no approved drug for IIH, so off label uses of a couple drugs are used. Once there is an approved drug, that is the automatic selection.
Here is an excerpt from the FDA in regard to when off label use is appropriate;
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