RE:RE:RE:RE:RE:RE:Clinical Trial Size in Orphan and Rare Diseases
it's nice to see companies taking advantage of the AA pathway.... From the article that Note posted.
"The FDA approval is based on data from a subset of patients in the BRUIN Phase 1/2 trial. The assessment of efficacy was based on 108 patients with CLL/SLL treated with Jaypirca who were previously treated with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
As you will note, the aprroval is based on 108 patients.