I'm with those who think Amarex is the big problem
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Posted On: 03/08/2021 12:30:31 PM
I'm with those who think Amarex is the big problem.
Back in May we removed "the under 65 only" restriction from the trial.
Knowing that these people had about 3.5 times the death rate, it should have been easy to convince the FDA at the time that either:
(a) ideally, these patients should be randomized separately, or
(b) the Statistical Analysis Plan should have been updated to accommodate two cohorts.
There was a 3.5% chance of the observed (or greater) age imbalance between the groups.
Amarex also botched the initial HIV BLA filing (mis-formatted tables), and was at least partly responsible for the botched final filing (un-accepted integrated safety analysis),
Back in May we removed "the under 65 only" restriction from the trial.
Knowing that these people had about 3.5 times the death rate, it should have been easy to convince the FDA at the time that either:
(a) ideally, these patients should be randomized separately, or
(b) the Statistical Analysis Plan should have been updated to accommodate two cohorts.
There was a 3.5% chance of the observed (or greater) age imbalance between the groups.
Amarex also botched the initial HIV BLA filing (mis-formatted tables), and was at least partly responsible for the botched final filing (un-accepted integrated safety analysis),
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