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Re: None

Saturday, 08/29/2020 7:16:30 AM

Saturday, August 29, 2020 7:16:30 AM

Post# of 426559
A few questions. First of all, I take it these results are unprecedented. No other drug has ever achieved this result.

As for a label change, wouldn't that require a broader FDA sponsored trial? Or can a label change be approved on the basis of this small trial? As for advertising, that would have to be FDA approved and I wonder if they can even include these results without going through another tortuous approval process.
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