I've been think about the probability of this happening, and the level of granularity that might be communicated by NP.Quote:Perhaps they are precluded from saying certain things but I don't believe "we met our primary end point," or "we had x amount of fatality in treatment, and y amount of fatality in Placebo" are taboo.
If the Day 28 death counts are disclosed, it would seem trivial for us to calculate the P-value.
However, what I don't know is how much the Secondary Outcome Measures (see below) can possibly influence the Primary Outcome Measures.
Question 1. Can those Secondaries 'tilt the scales' in a meaningful way?
Also, and I haven't posed this question to the board yet, but the Secondary Outcome of the S/C trial does NOT include Dr.BP's blood tests that are in the M/M protocol. I can imagine CytoDyn intentionally omitting that Secondary because Dr.BP may not have wanted to commit to performing those tests for the entire 390 subject trial.
Question 2. Do we think Dr.BP might have agreed to perform those tests for at least the first 50 interim subjects -- so that we could tell the whole efficacy story to the FDA?
I ask this because without Dr.BP's blood tests for the interim subjects, I think we have a harder time swaying the FDA on what exactly leronlimab does for that cohort of patients (as the EIND patient's blood tests are probably always going to be considered anecdotal).
P3 S/C Trial
Secondary Outcome Measures:
1. All-cause mortality at Day 14 [ Time Frame: Day 14 ]
- Day 0 refers to the data of randomization/first treatment.
2. Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
- 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 of subject at Day 28 (on a 7 point ordinal scale) [ Time Frame: Day 28 ]
- 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.
4 Change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. [ Time Frame: Day 14 ]
- The SOFA score assessment will be based on PaO2/FiO2, platelets, Glasgow coma scale (GCS), bilirubin, Mean arterial pressure OR administration of vasoactive agents required, and Serum creatinine
