$RLFTF DD (opinion) by IN on Ya-h00: Apparently, not everyone here is blessed with the ability to read a PR. Let me dissect it for those people again:
* "Zyesami Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival" => You don't claim that if it's not true, or you want to end up in court/jail
* "Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013)" => That means ALL 196 patients from all 10 hospitals taken together were evaluated according to the pre-determined primary endpoint metrics. This analysis has shown improved recovery from respiratory failure (definition of respiratory failure per the FDA) both at day 28 and day 60. This has no value like "number of days" or so attached because "recovery" is a binary event. But whatever the difference is, the P values tell us that it is very unlikely due to chance. Much better than the "gold standard" of P < 0.05.
* "also demonstrated a meaningful benefit in survival (P under .001) after controlling for ventilation status and treatment site" => Let's get to the controlling part. That means that you normalize your data in a way where you try to eliminate external factors, so that the results really reflect the effect of the drug you're studying. ALL patients get the adjustment applied, placebo or treatment alike. Adjustments need to be scientifically valid and usually are agreed with the FDA. Severity is one of those external factors that are expressly encouraged to be controlled for in FDA guidance. Adjusting for ventilator status (HFNC, positive pressure, ventilator) IS adjusting for severity. Adjusting for treatment sites (tertiary vs. regional), when some are over 200 % ICU capacity, seems like a very valid external factor not intrinsic to how the drug works as well. The adjustment is for the mortality evaluation ONLY. All said and done, the treatment arm did better than placebo AND that fact is less likely to be down to chance than 1 in 1000 (P under 0.001)!
* "In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals." => IN ADDITION to ALL PATIENTS mentioned above, we'll now get more detailed data on a subgroup. Those patients previously mentioned in the 28 day interim readout. Those that haven't progressed to a ventilator (which nobody will hopefully have to do once Zyesami is in hospitals), those which were treated at hospitals that had enough capacity around and at least a specialist on call at all times. Basically the most meaningful patient group to really show what's going on with this drug biologically in a patient.
* "In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). => In other words, that's a clinically meaningful improvement in getting off assisted breathing, which is very unlikely to be down to chance. So the drug works.
* "Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007)." => Yes, the tertiary centers do a good job now keeping patients alive. Much more than the 20-30 % rates being circulated on the $CYDY board for example. But with Zyesami and good care, when you go to a hospital with critical COVID, you have an 84 % chance of surviving that now for at least 60 days! That's bigly. COVID will be a flu soon (especially when we get the inhalers out).
* "To the company's knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial." => We're the first. The one. The only.
* "On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration ("FDA"
for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA)." => As stated in the conference call, we have the data we need IN HAND to apply NOW for EUA. Dr. Javitt is no amateur with the FDA. And, he even thinks this RCT will serve as the basis for a New Drug Approval, because ALL ENDPOINTS WERE MET! This was a blazing success!
* "Zyesami Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival" => You don't claim that if it's not true, or you want to end up in court/jail
* "Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013)" => That means ALL 196 patients from all 10 hospitals taken together were evaluated according to the pre-determined primary endpoint metrics. This analysis has shown improved recovery from respiratory failure (definition of respiratory failure per the FDA) both at day 28 and day 60. This has no value like "number of days" or so attached because "recovery" is a binary event. But whatever the difference is, the P values tell us that it is very unlikely due to chance. Much better than the "gold standard" of P < 0.05.
* "also demonstrated a meaningful benefit in survival (P under .001) after controlling for ventilation status and treatment site" => Let's get to the controlling part. That means that you normalize your data in a way where you try to eliminate external factors, so that the results really reflect the effect of the drug you're studying. ALL patients get the adjustment applied, placebo or treatment alike. Adjustments need to be scientifically valid and usually are agreed with the FDA. Severity is one of those external factors that are expressly encouraged to be controlled for in FDA guidance. Adjusting for ventilator status (HFNC, positive pressure, ventilator) IS adjusting for severity. Adjusting for treatment sites (tertiary vs. regional), when some are over 200 % ICU capacity, seems like a very valid external factor not intrinsic to how the drug works as well. The adjustment is for the mortality evaluation ONLY. All said and done, the treatment arm did better than placebo AND that fact is less likely to be down to chance than 1 in 1000 (P under 0.001)!
* "In addition to the robust overall significance across all 196 treated patients at all 10 clinical sites, the prespecified analysis of recovery from respiratory failure is clinically and statistically significant in the 127 patients treated by High Flow Nasal Cannula (HFNC) (P = .02), compared to those treated with mechanical or non-invasive ventilation at tertiary care hospitals." => IN ADDITION to ALL PATIENTS mentioned above, we'll now get more detailed data on a subgroup. Those patients previously mentioned in the 28 day interim readout. Those that haven't progressed to a ventilator (which nobody will hopefully have to do once Zyesami is in hospitals), those which were treated at hospitals that had enough capacity around and at least a specialist on call at all times. Basically the most meaningful patient group to really show what's going on with this drug biologically in a patient.
* "In this group, ZYESAMI™ patients had a 71% chance of successful recovery by day 28 vs. 48% in the placebo group (P = .017) and a 75% rate of successful recovery by day 60 vs. 55% in the placebo group (P = .036). => In other words, that's a clinically meaningful improvement in getting off assisted breathing, which is very unlikely to be down to chance. So the drug works.
* "Eighty-four percent (84%) of HFNC patients treated at tertiary medical centers with ZYESAMI™ survived to day 60 compared with 60% of those treated with placebo (P = .007)." => Yes, the tertiary centers do a good job now keeping patients alive. Much more than the 20-30 % rates being circulated on the $CYDY board for example. But with Zyesami and good care, when you go to a hospital with critical COVID, you have an 84 % chance of surviving that now for at least 60 days! That's bigly. COVID will be a flu soon (especially when we get the inhalers out).
* "To the company's knowledge, ZYESAMI™ is the first COVID-19 therapeutic to demonstrate advantages in both survival and recovery from critical COVID-19 in a randomized, double-blind multicenter trial." => We're the first. The one. The only.
* "On the basis of these findings, NeuroRx plans to apply immediately to the United States Food and Drug Administration ("FDA"
for Emergency Use Authorization (EUA) and to subsequently submit a New Drug Application (NDA)." => As stated in the conference call, we have the data we need IN HAND to apply NOW for EUA. Dr. Javitt is no amateur with the FDA. And, he even thinks this RCT will serve as the basis for a New Drug Approval, because ALL ENDPOINTS WERE MET! This was a blazing success! Mondobiotech Holding AG Basel (RLFTF) Stock Research Links
$MJ
