These are our CD-12 trial measures:
Outcome Measures
Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.
Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
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.
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.
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
While the primary outcome can be possibly calculated few hours after un-binding, the characterization, tabulation and calculations of Change in clinical status days 7 and 28 plus the Organ Failure Assessment day 14 takes some time.
However, more than a couple of weeks now is a good time-span for results to be analyzed. We need to remember that CytoDyn will receive "partial" information, in a way, from the board and, then, CytoDyn will have to decide what and how to pass on the information to us.
Obviously positive news will be widely spread to impact positively the SP and, if it is the case, not so positive, will be packaged and delivered "at due time", meaning at a timing of less impact.
This happens with every biotech reporting trial results. More so when the company has only one product like us.
Imo, we will be receiving news (even if partial) soon (not a surprise here), the time period since trial end would indicate that the next few days call for waking up at 5:30 Eastern and be coffee-in-hand-and-stomach at front of computer screens by 5:55 A.M.
Good luck to you all !!!, the rubber is hitting the road finally for our first go at a possible approval or authorization.
An optimistic "take" on results, however purely speculative:
https://insiderfinancial.com/handicapping-cyt...ut/180558/
Outcome Measures
Primary Outcome Measures :
All-cause mortality at Day 28 [ Time Frame: Day 28 ]
Day 0 refers to the data of randomization/first treatment.
Secondary Outcome Measures :
All-cause mortality at Day 14 [ Time Frame: Day 14 ]
Day 0 refers to the data of randomization/first treatment.
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.
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.
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
While the primary outcome can be possibly calculated few hours after un-binding, the characterization, tabulation and calculations of Change in clinical status days 7 and 28 plus the Organ Failure Assessment day 14 takes some time.
However, more than a couple of weeks now is a good time-span for results to be analyzed. We need to remember that CytoDyn will receive "partial" information, in a way, from the board and, then, CytoDyn will have to decide what and how to pass on the information to us.
Obviously positive news will be widely spread to impact positively the SP and, if it is the case, not so positive, will be packaged and delivered "at due time", meaning at a timing of less impact.
This happens with every biotech reporting trial results. More so when the company has only one product like us.
Imo, we will be receiving news (even if partial) soon (not a surprise here), the time period since trial end would indicate that the next few days call for waking up at 5:30 Eastern and be coffee-in-hand-and-stomach at front of computer screens by 5:55 A.M.
Good luck to you all !!!, the rubber is hitting the road finally for our first go at a possible approval or authorization.
An optimistic "take" on results, however purely speculative:
https://insiderfinancial.com/handicapping-cyt...ut/180558/
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