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Posted On: 05/21/2021 2:01:28 PM
Post# of 145880
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Re: KenChowder #91203
Quote:
By the way, the company had ALSO initially proposed 14-day mortality as the primary endpoint – again nixed by the FDA.
I recall that they increased the trial primary endpoint from 14-days to 28-days, and made 14-days a secondary endpoint, upon advice given to them by somebody. I don't recall who it was, or even if they disclosed who gave the advice.
But, I wonder why this is not talked about more. Had they been given 4 weekly doses, instead of just 2 weekly doses, this probably would have been a non-issue.
But, the real question is why were they told to increase it from 14-days to 28-days, at the same time as restricting the doses to days 0 and 7.
FDA or Amarex, whoever gave them this "advice" is likely incompetent or corrupt.
What was the thought process of going from 14-days to 28-days without increasing the doses? That explanation could weed out which it is, incompetence or corruption or something else.
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