Cytodyn Inc (CYDY)

[stockorus]

The FDA letter said this:

In the smaller study that CytoDyn conducted in patients with mild-to-moderate COVID-19 disease (CD10), there was no observed effect of the drug on the study’s primary endpoint or on any of the secondary endpoints... Additionally, none of the secondary endpoints were met in this study, including mortality, time to symptom resolution, and time to return to normal activity.

The Clinicaltrials page specifically puts NEWS2 as a secondary endpoint including at Day 14.

So, if as you say, NEWS2 had SS at 14 days, then that is opposed to the FDA letter. In an ideal world, Cytodyn would then either confirm their original stance on SS, or explain how FDA is justified in saying NO to that specific point and admit they were wrong to PR NEWS2. It is also possible that the difference in their conclusions comes down to some trivial technicality. I can understand if the Company did not want to ruffle feathers any more but it leaves a bad taste for the shareholder who feels left hanging. (And the price we pay is HUGE, since the FDA's comprehensive denial of evidence of efficacy would have been greatly undermined if they had to admit NEWS2 as SS.)

https://www.clinicaltrials.gov/ct2/show/NCT04343651?term=Leronlimab&draw=1&rank=6

Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Days 3, 7, and 14 ]
This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). Higher scores mean a worse outcome.