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Posted On: 02/16/2021 12:17:16 AM
Post# of 148893
Re: MD VIROLOGIST #78059
Aviptadil primary endpoint is a dont care as it relates to CD12.
I tried to highlight the aviptadil results because of the deaths in the aviptadil trial placebo arm:
31 patients
9 deaths between day zero and day 28
21 additional deaths between day 28 and day 77
Massive deaths outside of the 28 day trial period.
Although the above numbers are drawn directly from Figure 5 on page 181 of the BRPA Jan 27 sec filing, the numbers are obviously corrupted.
The listed numbers underneath the Figure 5 data plot do not match the data plot.
Regardless of the mismatch, the Figure 5 dataplot indicates at least twice as many aviptadil placebo patients died after day 28 as before day 28.
In this case aviptadil is massively effective, but aviptadil does not reduce mortality inside of 28 days.
The FDA is no doubt confounded with this situation and will take a minimum of weeks to sort it out for aviptadil and provide direction.
Why does RLFTF/NeuroRx/BRPA face this situation?
Perhaps it is because the SOC has managed to extend the lifespan of critical patients, but only by about a month or two.
A month or two is enough to totally screw up CD12.
This delayed critical covid death could explain why the CD12 overall mortality is only 22%. The patients are not dying until later than 28 days.
A totally confounding situation for all involved.
However, if CD12 placebo 28 day mortality is 30% and trial deaths inside 28 days are reduced from the 87 total deaths already reported, then leronlimab efficacy relative to placebo climbs even higher.
If the SOC has moved covid deaths mostly outside of 28 days, that is a tremondously confounding factor for interpreting the results of CD12 for both CYDY as well as the FDA. And that could lead to delays.
I tried to highlight the aviptadil results because of the deaths in the aviptadil trial placebo arm:
31 patients
9 deaths between day zero and day 28
21 additional deaths between day 28 and day 77
Massive deaths outside of the 28 day trial period.
Although the above numbers are drawn directly from Figure 5 on page 181 of the BRPA Jan 27 sec filing, the numbers are obviously corrupted.
The listed numbers underneath the Figure 5 data plot do not match the data plot.
Regardless of the mismatch, the Figure 5 dataplot indicates at least twice as many aviptadil placebo patients died after day 28 as before day 28.
In this case aviptadil is massively effective, but aviptadil does not reduce mortality inside of 28 days.
The FDA is no doubt confounded with this situation and will take a minimum of weeks to sort it out for aviptadil and provide direction.
Why does RLFTF/NeuroRx/BRPA face this situation?
Perhaps it is because the SOC has managed to extend the lifespan of critical patients, but only by about a month or two.
A month or two is enough to totally screw up CD12.
This delayed critical covid death could explain why the CD12 overall mortality is only 22%. The patients are not dying until later than 28 days.
A totally confounding situation for all involved.
However, if CD12 placebo 28 day mortality is 30% and trial deaths inside 28 days are reduced from the 87 total deaths already reported, then leronlimab efficacy relative to placebo climbs even higher.
If the SOC has moved covid deaths mostly outside of 28 days, that is a tremondously confounding factor for interpreting the results of CD12 for both CYDY as well as the FDA. And that could lead to delays.
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