Reminder of meaningful benefits to non-TI patients....

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Hoosier Investor
Posts: 128
Joined: Thu Jun 18, 2020 5:48 pm

Reminder of meaningful benefits to non-TI patients....

Post by Hoosier Investor » Tue Mar 12, 2024 5:10 pm

I just wanted to remind folks that the so-called "non-responder" group included....
1) Very sick patients coming into the trial with high (>6 units) transfusion burdens.
2) Patients who realized a meaningful reduction in their transfusion burden (but maybe didn't realize full T-I status)
3) Patients who realized a meaningful increase in their hemoglobin levels.

The Geron staff (and data) will remind/clarify the meaningful benefits observed within the "non-TI" patient population. The FDA language implies a black/white "response vs. non-response" outcome of the trial. However, as I recall, there were significant improvements (hemoglobin levels & transfusion burdens) observed within the group of patients who didn't realize (or count towards) the trial's official T-I rate.

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