Actually pretty incredible in rare disease! I’m pretty sure they could have had more by now, however that isn’t going to help the “intent to treat population” that must be included on the trial to receive Regulatory Approval (ie accelerated approval) for Paediatrics & Patients in China & Asia. If we can combine all these patients in one Ph3, cost saving & time saving to get to commercialisation.
So last year, I actually found the ANN, they had recruited 90 patients. Now they have to save spots for others on Ph3 - Adolescents & Asian population, plus other sites in EU. When you understand the whole “intent to treat population” thing, then you will understand how recruitment is carried out. It’s not hardest & fastest in this case.
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