It depends on what/who the authorities approve the use for.
This will be in the form of a label.
EG. Say there are 100 people and 25 people are suitable candidates for the dose/treatment based on the approved label. The other 75 people aren’t suitable unless the product label is expanded through another application to the health authority to include some of the other 75 people.
If the product is unbelievably effective/ superior to alternative treatments - then there is a chance that the product label might be approved over time and multiple applications, to include say 95/100 patients
DYOR
question about therapy, page-2
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