Lvegun, I will listen again. I believe he addre
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Posted On: 08/12/2020 8:56:24 PM
Lvegun,
I will listen again. I believe he addressed phase 3 in two ways.
The first was that a larger trial would achieve statistical significance in the CD10 primary endpoint (improvement in subjective criteria of myalgia, cough, fever, dyspnea). You are correct that more patients would be a pill.
The second point (I don't believe I misunderstood), was that NEWS2 can be made primary endpoint in a phase 3 and would have statistical significance with trial size in phase 2 CD10 as that is exactly what Cytodyn achieved.
Logically then, Nader said/inferred that there is no need for the phase 3 as the trial they would conduct has essentially already been completed with significant results.
Thanks for the correction.
I will listen again. I believe he addressed phase 3 in two ways.
The first was that a larger trial would achieve statistical significance in the CD10 primary endpoint (improvement in subjective criteria of myalgia, cough, fever, dyspnea). You are correct that more patients would be a pill.
The second point (I don't believe I misunderstood), was that NEWS2 can be made primary endpoint in a phase 3 and would have statistical significance with trial size in phase 2 CD10 as that is exactly what Cytodyn achieved.
Logically then, Nader said/inferred that there is no need for the phase 3 as the trial they would conduct has essentially already been completed with significant results.
Thanks for the correction.
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