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Actually, it was the opposite. The rationale

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BlackDoggie   Friday, 11/10/17 11:02:37 AM
Re: trding post# 18093
Post # of 18301 
Actually, it was the opposite. The rationale was that 30 would give statistical significance, but not clinical significance. That's a BS answer, because they would/should have known the number they (FDA) would need up front for either. Something changed in the ask - from one side or the other - in my opinion.

And again, the data was still blinded, so there's no way that the FDA looked at the data and decided they needed more.


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