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Re: misiu143 post# 18707

Friday, 12/08/2017 3:59:22 PM

Friday, December 08, 2017 3:59:22 PM

Post# of 233634
The low "N' is due to an unmet disease state, Fast track designation, FADASIA, which is relatively new. However, the pass on a low FDA "N" mandate still requires statistical significance..no matter what the number. If I were a patient or a prescribing physician, I would lean heavily towards the "N" =1000 efficacy/safety data over the struggling "N" =50 that ID shows some neutrality. And, a relatively high Rebound and injection site SA.
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