Craig, let’s pretend you’re Amarex’s attorne
Post# of 154078
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Posted On: 11/03/2022 8:36:21 PM
Re: craigakess #130112
Craig, let’s pretend you’re Amarex’s attorney. How would you argue that Amarex’s failure to follow instructions from the FDA, and their failure to create a usable data set, were not gross negligence?
Inquiring minds want to know.
Just to help you out, so that you don’t have to look it up, “remember that” not only did Amarex fail to put the data in the correct categories on the FDA documents, after the FDA explicitly instructed them how to do so, they put additional things in the wrong categories, and the data itself lacked things like the dates that people were dosed, and other information involving individual test subjects that are always carefully logged in.
Then, please tell us how you would argue that 3 different monitoring firms said the data were not salvageable to the level that was needed to be used in the FDA filing — said filing being the reason for Amarex being hired to run clinical trials — and that this is not gross negligence.
Inquiring minds want to know.
Just to help you out, so that you don’t have to look it up, “remember that” not only did Amarex fail to put the data in the correct categories on the FDA documents, after the FDA explicitly instructed them how to do so, they put additional things in the wrong categories, and the data itself lacked things like the dates that people were dosed, and other information involving individual test subjects that are always carefully logged in.
Then, please tell us how you would argue that 3 different monitoring firms said the data were not salvageable to the level that was needed to be used in the FDA filing — said filing being the reason for Amarex being hired to run clinical trials — and that this is not gross negligence.
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