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Posted On: 03/06/2021 12:05:22 PM
Post# of 148902
So we finally got our long expected data. 
We obviously have good results but unfortunately missed the PE if we count the severe patients.
I think we should have shown improvement in this group as well but, obviously, not good enough for statistical purposes. Looking forward to Monday conference and paper to see what kind of improvement we got in this group.
Only 15.74% of patients were critical (62/394) so, this skewed results if our improvement performance in Severe was not significant.
EUA is precisely for that:
The BIG question is how many Critical patients will FDA be happy with before they issue a EUA. 62 is a good number but might not be "powered" enough for hem to do it.
Our results for Critical are better than pretty much anybody else's out there and a 24% reduction in all-cause death and 6 days stay reduction is nothing to laugh at.
The numbers analysis is not straightforward as we don’t know what the exact distribution between SOC and Vyrologix is (we know is approximately 2:1) . One possible scenario would be 43/19 (VX/SOC) with 29/17 total deaths (67.4/89.5%) and a relative improvement of 24.6% (absolute of 22.1%). Out of curiosity, this would produce a p-value of 0.028, however, one more survival in the SOC group will bring this to 0.1275.
So, without more information is better not to speculate.
What is clear is that we need more patients to properly power our Critical results which are very good for EUA approval and, even, statistically significant if we increase the total Critical patients population.
Looking forward to more information tomorrow. We have a drug that works !!!. Now we need to convince rapidly the regulatory agencies we make a difference in Critical.
And start saving lives.
Quote:
1. Survival benefit: There was a 24% reduction in all-cause mortality (primary endpoint of the study) in the leronlimab versus placebo.
2. Shortened time to recovery: The average length of hospital stay was reduced by 6 days for patients who received leronlimab with ”commonly used COVID-19 treatments,” also referred to as “Standard of Care” or “SoC,” compared to placebo patients who received SoC only, with a statistically significant p-value of 0.005.
We obviously have good results but unfortunately missed the PE if we count the severe patients.
I think we should have shown improvement in this group as well but, obviously, not good enough for statistical purposes. Looking forward to Monday conference and paper to see what kind of improvement we got in this group.
Only 15.74% of patients were critical (62/394) so, this skewed results if our improvement performance in Severe was not significant.
EUA is precisely for that:
Quote:
- The FDA acknowledged that normal P-Factor is not the bar they want to set to evaluate Treatments for S/C during a pandemic.
- If any Treatment shows good improvement over SOC for S/C patients, the FDA will be inclined to offer an EUA and continue evaluating said Treatment for either full approval or discontinuance of the EUA.
- S/C patients have no choice. Any Treatment that is SAFE and gives them a better chance of survival WILL receive an EUA as the alternative is death.
- The FDA will be looking to pair up viable drugs to improve that chance of survival through partnerships.
The BIG question is how many Critical patients will FDA be happy with before they issue a EUA. 62 is a good number but might not be "powered" enough for hem to do it.
Our results for Critical are better than pretty much anybody else's out there and a 24% reduction in all-cause death and 6 days stay reduction is nothing to laugh at.
The numbers analysis is not straightforward as we don’t know what the exact distribution between SOC and Vyrologix is (we know is approximately 2:1) . One possible scenario would be 43/19 (VX/SOC) with 29/17 total deaths (67.4/89.5%) and a relative improvement of 24.6% (absolute of 22.1%). Out of curiosity, this would produce a p-value of 0.028, however, one more survival in the SOC group will bring this to 0.1275.
So, without more information is better not to speculate.
What is clear is that we need more patients to properly power our Critical results which are very good for EUA approval and, even, statistically significant if we increase the total Critical patients population.
Looking forward to more information tomorrow. We have a drug that works !!!. Now we need to convince rapidly the regulatory agencies we make a difference in Critical.
And start saving lives.
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