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Posted On: 07/15/2020 8:52:41 PM
Post# of 155794
Re: Longestyard #43173
“CI what is your educated guess or opinion on what the forthcoming data results will show? As far as being good to not good or interpreted as not good? 50/50 good/ng, 60/40 good/ng? What are you thinking personally?”
IMO, I believe that data from the severe trial will be clear: leronlimab statistically and significantly reduces the death rate in severe patients when compared to placebo. My belief is based on the data from the initial EINDs and the fact that outside of the first 11 patients, none of the other 54 died after receiving leronlimab (NP stated this during a CC or interview, but I can’t recall which one). Of course we don’t know how severe each EIND patient was, but I don’t think CYDY was filling EINDs for patients with a minimal cough and fever.
In regards to the M2M trial, I’m mixed. The primary endpoints aren’t as clear cut, but the secondary are, such as hospitalization rate, length of hospitalization, ventilation rate, length of ventilation and death rate. I don’t know if leronlimab will be approved on just the primary endpoints (i.e. patients feel better) but instead on the big issues that COVID19 is causing: hospitalizations and deaths. Also, the small 86 person trial concerns me and I’m unsure why the FDA approves a 75 person M2M and a 395 patient severe trial. The M2M should’ve at least had 150-200 patients. I suspect the data will be good but the FDA will ask for a larger trial.
IMO, I believe that data from the severe trial will be clear: leronlimab statistically and significantly reduces the death rate in severe patients when compared to placebo. My belief is based on the data from the initial EINDs and the fact that outside of the first 11 patients, none of the other 54 died after receiving leronlimab (NP stated this during a CC or interview, but I can’t recall which one). Of course we don’t know how severe each EIND patient was, but I don’t think CYDY was filling EINDs for patients with a minimal cough and fever.
In regards to the M2M trial, I’m mixed. The primary endpoints aren’t as clear cut, but the secondary are, such as hospitalization rate, length of hospitalization, ventilation rate, length of ventilation and death rate. I don’t know if leronlimab will be approved on just the primary endpoints (i.e. patients feel better) but instead on the big issues that COVID19 is causing: hospitalizations and deaths. Also, the small 86 person trial concerns me and I’m unsure why the FDA approves a 75 person M2M and a 395 patient severe trial. The M2M should’ve at least had 150-200 patients. I suspect the data will be good but the FDA will ask for a larger trial.
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