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Monday, April 16, 2018 12:16:23 PM
The lack of a control arm seems like a pretty big deal to me. This seems particularly important when it feels like there is an element of Imetelstat being effective, but not knowing what the precise cause and effect are. Patients who are given imetelstat have longer OS, but the exact reason why seems obscure. At the end of the day, if I were patient, I wouldn't care...just give me the thing that helps me live longer, but in terms of FDA approval, I imagine this matters? Won't there have to be a Phase III with a control arm for IMET to be approved?
What am I missing/getting wrong? Thanks in advance to those who are willing to take the time to address.
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