My concern is not with the safety of ISLA 101, but with the validity of its challenge test, DENV-1-LVHC.
From my understanding, ILA want to prove efficacy of ISLA 101 using a test that has been only validated on 7 subjects, or something.
ILA is still waiting on being granted its IND before it can begin the study, is it not?…I am wondering whether the FDA will reject the trial design based on ILA using a poorly validated test of ISLA 101's effectiveness.
My concern is not with the safety of ISLA 101, but with the...
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