Do you think the CMS is going to analyze data? And do you not realize that Ilfeld himself is saying the sample size is too small from which to draw that kind of conclusion?
I studied a lot of published research in journals in my academic days. My wife publishes her research in journals. If a researcher says "we didn't meet our endpoint" or "there isn't enough data to draw a conclusion," the audience, including the CMS and your Joe Blow, is not going to analyze the data and cite that conclusion.
But I reiterate: there might be political pressure on the CMS to approve MORE devices and drugs, not LESS. So maybe it won't matter. Again, not the point of the discussion -- the point is that the company isn't doing anything else in preparation for the NOPAIN Act. You are the one trying to change the subject and move the goalpost.
Whatever. Slap That Ask if you think the CEO is doing such a great job. Show her your support.
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