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Posted On: 09/23/2020 3:55:45 PM
Post# of 145900
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Re: Borel Fields #57561
Quote:I could see the FDA not wanting the interim results used to recruit patients.
A caveat: I heard NP say the data could be released to CytoDyn. I'm not sure I heard him say the data could be released to the public. I hope the FDA wouldn't object to interim results being used to help recruit study patients.
However, at the same time, I wonder if there is possibly a mechanism by which CytoDyn can request that the data provided to the DSMC can also be shared with other ex-US regulatory agencies WITHOUT a penalty.
I ask this because other countries might very well have lower thresholds for interim approval and it would be an absolute shame if the 'still blinded' data could not be shared with those countries, on a confidential basis, in an effort to gain approval.
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