Cytodyn Inc (CYDY)

[CTMedic]

I'm late responding, as I see this question has been answered by Ohm and others.

As noted, the interim evaluation is for efficacy. DSMC can, based on their assessment of the data, recommend stopping the trial as a success, or modification (CD12 is an adaptive trial).

The primary and secondary endpoints will be evaluated. What level of success/statistical significance to prompt a response is a bit uncertain (at least to me).

P<0.05 in primary would have to be released. I don't know what would happen if primary insufficient but secondary are. Likely continue to full enrollment, though considering the pressing nature (Pandemic and Trump re-election), maybe EUA would be granted, especially in consideration of EIND and CD10 as well.

Primary endpoint is mortality at day 28.

Secondary endpoints:

1.Mortality at day 14

2. Change in clinical status day 14 on 7 point ordinal scale (A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.)

3. Change in clinical status day 28

4. Change from baseline in sequential organ failure assessment