I have a recollection (possibly from something NP
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Posted On: 06/25/2020 12:44:47 AM
I have a recollection (possibly from something NP said a couple of weeks ago) that the FDA might agree to to view the results of both trials on a cumulative basis in order to offset the intrinsically low power of each small sample size.
I don't know if NP was just shooting from the hip, but does anyone else remember this happening?
If that memory is correct, I wonder if there is a plan for CytoDyn / Amarex to process the results from both trials as they become available -- but present them to the FDA at the same exact time.
And that causes me to wonder if the FDA will issue the equivalent of a non-disclosure order, preventing NP from announcing the preliminary results from the first available trial (P3 S/C) to investors.
Happy to get input from the board on this.
I don't know if NP was just shooting from the hip, but does anyone else remember this happening?
If that memory is correct, I wonder if there is a plan for CytoDyn / Amarex to process the results from both trials as they become available -- but present them to the FDA at the same exact time.
And that causes me to wonder if the FDA will issue the equivalent of a non-disclosure order, preventing NP from announcing the preliminary results from the first available trial (P3 S/C) to investors.
Happy to get input from the board on this.
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