Remember when I correctly infered in Oct. based on cross-arms mortality data disclosed by $CYDY that CD12 trial would not be stopped for early efficacy?
With the proof above I will infer again with some maths that CD12 is heading toward failure for both severes and criticals
For $CYDY lovers, a quick primer:
« …SAEs that are consequences of the underlying disease…would be reportable…however, if an aggregate analysis indicated that the events were occurring more frequently in the drug treatment group than in a control group" fda.gov/media/94879/do…
which means if the $CYDY trial DSMC had seen more deaths in the Leronlimab arm (vs Standard Of Care arm) for intubated patients, they would have had to report it to the FDA. Not required to unblind patient-level data though: as this document says, aggregate analysis is sufficient
To sum it up, 3 $CYDY things to discuss on Monday (have some work to close so maybe ~10 EST) 1) What is going on with the FDA and CD12 intubated patients? 2) Could the FDA obtain early access to trial data? 3) If intubated segment failed, can the trial remainder still succeed?
An as an added bonus this will include a list of official questions for @CytoDyn next conference call this week, in particular regarding whether its Chief Financial Officer knew a very specific fact when he planned his stock sale on Nov 12th
$CYDY
$CYDY just corrected its past PR this morning, retracting the eIND criteria it communicated earlier. Consequently, I retract my analysis
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As promised, and after $CYDY corrected its erroneous eIND PR, I will discuss in this thread 3 topics: 1) Can its CD12 trial meet primary endpoint statistical significance? 2) Did the FDA obtain early access to trial data and why? 3) Questions for Cytodyn's wednesday conf. call
1) Can its CD12 trial meet primary endpoint statistical significance?
We know from $CYDY SEC documents the following facts about its CD12 trial (for severe/critical COVID patients):
We also reviewed 50+ research papers who ALL indicate that until May 2020, Standard Of Care for all severe/critical patients (excluding to be FAIR papers handpicking a specific subset like non intubated patients or ICU patients) until May had a mortality rate of 12-25% max.
$CYDY