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Re: dcaf7 post# 171

Sunday, 01/22/2023 1:20:23 PM

Sunday, January 22, 2023 1:20:23 PM

Post# of 575
I just listened to the Dec 11 APTO presentation again with focus on the monotherapy approval strategy. It appears that the decision to take AML r/r patients to HSCT will be left to the treating physicians. APTO believes that it should get credit for any CR patients that go to HSCT and will discuss this with the FDA. Everyone understands that many of the CR patients will not be treated with TUSP for six months before they get an HSCT. APTO also plans to petition the FDA to allow patients that get a HSCT to go back on TUSP in a maintenance setting. So I do not believe that the response duration is a straightforward DoR. It will likely be a hybrid of the above and agreed to with the FDA. N. Daver suggested that a CRc in the range of 20% should be viable for potential AA.
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