First of all I’m not worried about the little eod short attack and neither should anyone. Here is simplified math to explain why I’m not worried about CYDY short term or long term.
Simplistic math. 45 deaths total of 195.
Forget Pvalues for a moment because we’re not trying to get approved for heart burn or high blood pressure where there are tons of approved drugs already and were in middle of pandemic. Literally the middle with 2nd wave just about flaring you in many places. Keep in mind leronlimab arm has twice as many Patients as it’s a 2-1 ratio Nadar wanted to be able to help the majority of patients in the trial. I’ve researched many large studies finding that avg of 30-35% avg mortality in severe critical which would put placebo at around 21 deaths and 24 in leronlimab. I’m not a Pvalue expert but if you double the 21 you now have a 1-1 comparison of 24 leronlimab 42 placebo this would be a mortality rate reduction of 57% reduction in mortality. Head of the FDA Steven Hahn quoted saying 35% mortality reduction is a dream number. That 35% reduction would be shown with 27 deaths in leronlimab and 18 in placebo. Which 18/65 in placebo group would be 27% mortality rate. I don’t believe placebo performed that well. If anything I believe most of the trial patients would have been in the severe almost critical and critical shape desperate for an experimental drug when whatever they were taking was failing. If that’s the case the placebo mortality might be much higher but let’s use 37% as example which would be 24 deaths in Placebo and 21 in leronlimab. This would have a pvalue low enough for approval. Any of the other scenarios should still get EUA in my opinion. There aren’t to many scenarios where I see placebo out performing or matching leronlimab given the fact when taken early enough in m/m reduced SAE 65% and avg mortality rate in EIND patients I believe was around 18%. If you use the 18% it would be 23 patients in leronlimab vs 22 in placebo once again Pvalue met and approval using all the data we currently have. Also keep in mind in recent Aviptidal study there was a 81% mortality rate in placebo. If that we’re the case it means there would be 52 deaths which literally means leronlimab being dead people back to life, which ironically has happened in several EIND patients. That Aviptidal press release just wows me can you imagine leronlimab going against an 80% placebo death rate...... we would be reducing mortality by 500-600% crazy!
Simplistic math. 45 deaths total of 195.
Forget Pvalues for a moment because we’re not trying to get approved for heart burn or high blood pressure where there are tons of approved drugs already and were in middle of pandemic. Literally the middle with 2nd wave just about flaring you in many places. Keep in mind leronlimab arm has twice as many Patients as it’s a 2-1 ratio Nadar wanted to be able to help the majority of patients in the trial. I’ve researched many large studies finding that avg of 30-35% avg mortality in severe critical which would put placebo at around 21 deaths and 24 in leronlimab. I’m not a Pvalue expert but if you double the 21 you now have a 1-1 comparison of 24 leronlimab 42 placebo this would be a mortality rate reduction of 57% reduction in mortality. Head of the FDA Steven Hahn quoted saying 35% mortality reduction is a dream number. That 35% reduction would be shown with 27 deaths in leronlimab and 18 in placebo. Which 18/65 in placebo group would be 27% mortality rate. I don’t believe placebo performed that well. If anything I believe most of the trial patients would have been in the severe almost critical and critical shape desperate for an experimental drug when whatever they were taking was failing. If that’s the case the placebo mortality might be much higher but let’s use 37% as example which would be 24 deaths in Placebo and 21 in leronlimab. This would have a pvalue low enough for approval. Any of the other scenarios should still get EUA in my opinion. There aren’t to many scenarios where I see placebo out performing or matching leronlimab given the fact when taken early enough in m/m reduced SAE 65% and avg mortality rate in EIND patients I believe was around 18%. If you use the 18% it would be 23 patients in leronlimab vs 22 in placebo once again Pvalue met and approval using all the data we currently have. Also keep in mind in recent Aviptidal study there was a 81% mortality rate in placebo. If that we’re the case it means there would be 52 deaths which literally means leronlimab being dead people back to life, which ironically has happened in several EIND patients. That Aviptidal press release just wows me can you imagine leronlimab going against an 80% placebo death rate...... we would be reducing mortality by 500-600% crazy!
9
