One poster from YMB summarized very well. If yo
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Posted On: 08/11/2020 8:30:34 PM
One poster from YMB summarized very well.
If you can sort through the noise, collectively this Board has some very knowledgeable people. For me, today was a bit undecipherable. And so I did what I usually do, go to those folks here who post in good faith, clearly have the knowledge and experience, and provide well-thought out points of view. Today, I appreciated the input of Marco, Xuejun, and Frank, knowing I have left a few others out. Of course you can all read their posts without my recitation, but what I found important in their posts today was as follows-- Marco, an MD with training in epidemiology and biostatistics originally posted “…. This report of the m/m trial changes the whole landscape dramatically. The statistically significant results of the NEWS2 endpoint is reasonable scientific proof that Leronlimab changes the course of COVID-19. It reasonably admits the scientific conclusion that Leronlimab decreases the morbidity and ultimately the mortality of COVID-19." Marco also noted that, “There is an ongoing discussion in the world of statistics about the use of p-value (frequentist statistics) as criterion of proof. It's a very subtle topic. For just one example, the usual cut off of 0.05 as the level required for significance is really just an arbitrary consensus. It makes sense in that we need uniform standards in medical research, but it's not an immutable criteria of truth; it's simply a judgment call on the chance that a clinical difference is an artifact of the random distribution of the mean of the treatment group to the mean of the placebo group as expressed in the standard deviation. IMO, the evidence is now reasonably actionable that a safe drug like Leronlimab should be approved for use in COVID-19.” Xuejun also an MD with training in Biostatistics (a PhD degree) has over 15 years of experience working for big pharma, followed up by responding to Marko that “I agree with your comments.” He went to explain that “if this drug were in the hands of BIg Pharma, this study would have 800 patients instead of 84 only and we would have more statistically significant endpoints. Also, it probably would have been a better study design to have subgroups of mild patients vs moderate patients.” He also noted that, “…Honestly speaking, I wouldn’t have spent too much resource and effort on the mild patients because of the MOA of this drug.” He pointed out that “it is the patients who are at risk of having cytokine release syndrome or already have it that can benefit from Leronlimab.”
Frank added “What people do not understand is that you can’t reduce mortality in mild and moderate COVID-19. You can only improve symptoms and make it less likely that such patient will experience complications in form of adverse events. And this is exactly what leronlimab is doing. I think FDA will see it exactly like this and regarding severe cases, FDA like we all are looking forward to the see interim analyses of the S/C trial. There you should also see clinical improvement, less required ventilation, reduced likelihood to experience complications, etc and a reduced mortality.
If you can sort through the noise, collectively this Board has some very knowledgeable people. For me, today was a bit undecipherable. And so I did what I usually do, go to those folks here who post in good faith, clearly have the knowledge and experience, and provide well-thought out points of view. Today, I appreciated the input of Marco, Xuejun, and Frank, knowing I have left a few others out. Of course you can all read their posts without my recitation, but what I found important in their posts today was as follows-- Marco, an MD with training in epidemiology and biostatistics originally posted “…. This report of the m/m trial changes the whole landscape dramatically. The statistically significant results of the NEWS2 endpoint is reasonable scientific proof that Leronlimab changes the course of COVID-19. It reasonably admits the scientific conclusion that Leronlimab decreases the morbidity and ultimately the mortality of COVID-19." Marco also noted that, “There is an ongoing discussion in the world of statistics about the use of p-value (frequentist statistics) as criterion of proof. It's a very subtle topic. For just one example, the usual cut off of 0.05 as the level required for significance is really just an arbitrary consensus. It makes sense in that we need uniform standards in medical research, but it's not an immutable criteria of truth; it's simply a judgment call on the chance that a clinical difference is an artifact of the random distribution of the mean of the treatment group to the mean of the placebo group as expressed in the standard deviation. IMO, the evidence is now reasonably actionable that a safe drug like Leronlimab should be approved for use in COVID-19.” Xuejun also an MD with training in Biostatistics (a PhD degree) has over 15 years of experience working for big pharma, followed up by responding to Marko that “I agree with your comments.” He went to explain that “if this drug were in the hands of BIg Pharma, this study would have 800 patients instead of 84 only and we would have more statistically significant endpoints. Also, it probably would have been a better study design to have subgroups of mild patients vs moderate patients.” He also noted that, “…Honestly speaking, I wouldn’t have spent too much resource and effort on the mild patients because of the MOA of this drug.” He pointed out that “it is the patients who are at risk of having cytokine release syndrome or already have it that can benefit from Leronlimab.”
Frank added “What people do not understand is that you can’t reduce mortality in mild and moderate COVID-19. You can only improve symptoms and make it less likely that such patient will experience complications in form of adverse events. And this is exactly what leronlimab is doing. I think FDA will see it exactly like this and regarding severe cases, FDA like we all are looking forward to the see interim analyses of the S/C trial. There you should also see clinical improvement, less required ventilation, reduced likelihood to experience complications, etc and a reduced mortality.
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