The PR Friday represents only 62 out of 384 folks in the trial.
Critical folks are more difficult to save vs severe.
Remdesivir (SOC) has mild efficacy for m/m but no efficacy for s/c.
Hey..... Remdesivir is approved for s/c and LL is 24% better for critical. Our s/c trial is not LL vs placebo (sugar water), it is LL vs remdesivir and steroids and everything they can throw at s/c to save them. If trial was LL vs placebo, we would have reduction in death of maybe 70%. Common Sense and tiny wisdom would say any improvement over SOC, if safe should be approved! And 24% improvement is not just "any improvement"!.
Brazil, Phillipines are desperate for help, they will be quick to request shipments of LL vials, but our FDA knowing this, knowing they will look foolish when other countries are saving folks with LL, our FDA "should" grant an EUA quickly before NP sell all vials. NP may have made an agreement with our FDA not to sell out of USA?
Yes, there are fewer deaths in the severe population, especially among the severe who were given LL. Fewer deaths, but what's important is the % of death reduction by LL, which could approach 100%, bringing overall trial % reduction in deaths up, and bring the "power" up due to 322 folks in severe group. LL prevents severe folks from advancing to critical and then death, SOC prevents severe advancing to critical at a much lower rate.
Ms Janet W. FDA recent comments "should" guarantee an EUA for Leronlimab: less emphasis on p value, more emphasis on safety and on demand/need, more emphasis on benefit and raw data.
I'll bet 100% of my large investment in CYDY, that leronlimab gets an EUA from the USA by Thursday. (Probably by Tuesday).
Critical folks are more difficult to save vs severe.
Remdesivir (SOC) has mild efficacy for m/m but no efficacy for s/c.
Hey..... Remdesivir is approved for s/c and LL is 24% better for critical. Our s/c trial is not LL vs placebo (sugar water), it is LL vs remdesivir and steroids and everything they can throw at s/c to save them. If trial was LL vs placebo, we would have reduction in death of maybe 70%. Common Sense and tiny wisdom would say any improvement over SOC, if safe should be approved! And 24% improvement is not just "any improvement"!.
Brazil, Phillipines are desperate for help, they will be quick to request shipments of LL vials, but our FDA knowing this, knowing they will look foolish when other countries are saving folks with LL, our FDA "should" grant an EUA quickly before NP sell all vials. NP may have made an agreement with our FDA not to sell out of USA?
Yes, there are fewer deaths in the severe population, especially among the severe who were given LL. Fewer deaths, but what's important is the % of death reduction by LL, which could approach 100%, bringing overall trial % reduction in deaths up, and bring the "power" up due to 322 folks in severe group. LL prevents severe folks from advancing to critical and then death, SOC prevents severe advancing to critical at a much lower rate.
Ms Janet W. FDA recent comments "should" guarantee an EUA for Leronlimab: less emphasis on p value, more emphasis on safety and on demand/need, more emphasis on benefit and raw data.
I'll bet 100% of my large investment in CYDY, that leronlimab gets an EUA from the USA by Thursday. (Probably by Tuesday).
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