$RLFTF (related) Primary Outcome is going to be ST
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Posted On: 02/18/2021 11:09:27 PM
$RLFTF (related) Primary Outcome is going to be STATISTICALLY SIGNIFICANT and here’s Why:
Today, 2/18/21, NeuroRx and Relief updated their clinical trials website to modify the primary outcome for Zyesami.
The original outcome was: resolution of respiratory failure at 28days
The new outcome is: cumulative distribution of time to respiratory failure resolution (without relapse over 7 days ( with concurrent survival thru day 28)
This is VERY important. Most patients improve by day 28 whether they got Zyesami or not. BUT the original outcome didn’t take into account the TEMPORAL relationship between those who improved and those who didn’t.
i.e If you were on high flow NC and got Zyesami, you got out of the hospital 11 days earlier than those folks who didn’t. However, since the average LOS for those without Zyesami was 24 days…their respiratory failure was improved by the 28 day mark and no significance was seen on the preliminary review.
HOWEVER, if you look at the TIME IT TAKES to get better…there is a statistical significance.
ex. Say Zyesami patients got out of the hospital on day 10 and say SOC patients got out on day 20. Respiratory failure HAD to have improved faster in the zyesami group to get them out of the hospital sooner….however, everyone was better by day 28.
As such, the overall 28 day respiratory failure improvement rate was the same, but HOW FAST the patients improved (the “temporal relationship”) was better in the Zyesami group.
This is why the primary outcome was updated. This is also likely why the warrants were up 20% today on no news. With the last patient enrolled on 12/24/20, 60 days is 2/22/21. That means all but 5 patient shave 60 day data known now and there has been a rolling review of results. Insiders know the results are statistically significant.
I predict we will eventually hear that:
LOS decrease from Zyesami to SOC was statistically significant
Survival at 60 days is statistically significant
Readmission rate at 60 days is statistically significant
Primary outcome of resolution of respiratory failure will be met based on temporal improvement vs SOC
post by vader 69
Today, 2/18/21, NeuroRx and Relief updated their clinical trials website to modify the primary outcome for Zyesami.
The original outcome was: resolution of respiratory failure at 28days
The new outcome is: cumulative distribution of time to respiratory failure resolution (without relapse over 7 days ( with concurrent survival thru day 28)
This is VERY important. Most patients improve by day 28 whether they got Zyesami or not. BUT the original outcome didn’t take into account the TEMPORAL relationship between those who improved and those who didn’t.
i.e If you were on high flow NC and got Zyesami, you got out of the hospital 11 days earlier than those folks who didn’t. However, since the average LOS for those without Zyesami was 24 days…their respiratory failure was improved by the 28 day mark and no significance was seen on the preliminary review.
HOWEVER, if you look at the TIME IT TAKES to get better…there is a statistical significance.
ex. Say Zyesami patients got out of the hospital on day 10 and say SOC patients got out on day 20. Respiratory failure HAD to have improved faster in the zyesami group to get them out of the hospital sooner….however, everyone was better by day 28.
As such, the overall 28 day respiratory failure improvement rate was the same, but HOW FAST the patients improved (the “temporal relationship”) was better in the Zyesami group.
This is why the primary outcome was updated. This is also likely why the warrants were up 20% today on no news. With the last patient enrolled on 12/24/20, 60 days is 2/22/21. That means all but 5 patient shave 60 day data known now and there has been a rolling review of results. Insiders know the results are statistically significant.
I predict we will eventually hear that:
LOS decrease from Zyesami to SOC was statistically significant
Survival at 60 days is statistically significant
Readmission rate at 60 days is statistically significant
Primary outcome of resolution of respiratory failure will be met based on temporal improvement vs SOC
post by vader 69
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