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Re: pearsby09 post# 18709

Friday, 12/08/2017 5:05:26 PM

Friday, December 08, 2017 5:05:26 PM

Post# of 233434
If this low "N" was such a problem then why did the FDA lower it from 300? Isn't that a more interesting question than why they increased it from 30 to 50? I think we all know that the trial has to show statistical significance to get through the approval process - that is how trials work. If you have such a big problem with the N=50 then maybe you should go work for the FDA and change things. Many things can be said about the FDA's process but like it or not biotechs have to deal the cards they are given and if the FDA wants 50, they get 50.
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