7 ms·
Only for orphan and ultra orphan diseases where there are so few patients that it’s not economically viable to do full clinical trials. There is also a breakth
by throwup238 2y ago
Only for orphan and ultra orphan diseases where there are so few patients that it’s not economically viable to do full clinical trials.
There is also a breakthrough therapy designation where the clinical evidence is solid enough to release the drug while they finish full trials but that’s only in exceptional cases.