Lest any be concerned that justdafacts continue to post without being called to task, I replied to him with a bit of a challenge.
I know it is a bit off topic, but he has garnered a bit of attention and created a bit of frustration among some of us.
If you don't venture to IHub, my recommendation is not to start. It's a bit unhealthy.
Jusdafacts,
Can you please let me know who "we" are and how you "know CD12 will be a flop?
"Now, now, now, Jerome...we all know CD12 will be a flop therefore will not be supportive of an EUA. "
I believe it presumptuous to argue that we all know this. There is a different between knowing and believing.
An outstanding book to help us appreciate the difference is "On Being Certain: Believing You Are Right Even When You Are Not", by Dr. Richard A. Burton, a neurologist at the University of California San Francisco. It has helped me differentiate between the feeling of certainty and objective knowledge.
I'm for the digression if this does not prove useful to you.
I have been carefully following the bits of available information from both the CD10 leronlimab trial and the DSMB actions during the course of the CD12 trial.
Please correct any factual errors in my assessment that you are able to identify. I appreciate that you and I likely have different interpretations of Cytodyn's prospects, but I am trying to determine the facts of the clinical and regulatory development of leronlimab.
Our beliefs about the future of Cytodyn are obviously each our own, and that we may not appreciate the actual facts of Cytodyn's clinical, regulatory and business development.
CD10, the trial for leronlimab in mild to moderate Covid-19 enrolled 75 patients with a SUBJECTIVE primary endpoint of change in symptom score, assessing fever, myalgia, dyspnea and cough.
You have quite appropriately noted that CD10 failed to demonstrate clinical significance in this endpoint, as the vast majority of patients, both those treated with leronlimab and placebo, recovered quickly (Thankfully for the patients).
However, the secondary endpoints measured a number of OBJECTIVE criteria predictive of worsening clinical condition. Leronlimab demonstrated statistically significant improvement in NEWS2, the National Early Warning Score 2, which measures important clinical signs:
respiration rate
oxygen saturation
supplemental oxygen
temperature
systolic blood pressure
heart rate
level of consciousness
The leronlimab group had a 50% improvement in NEWS2 scores versus 20% in placebo.
In addition to these measurements, the SAFETY of leronlimab was tracked, with a 62% reduction in serious adverse events in the group receiving leronlimab.
In essence, leronlimab was demonstrated to be SAFER than water.
Granted, this was only a phase 2 trial in mild to moderate patients. These results were effectively met with a yawn by the FDA, despite their being markedly better than the time to clinical improvement results upon which remdesivir was approved.
The Cytodyn CD12 trial, as we all know, is nearly complete.
This trial has been reviewed twice by the DSMB, being authorized TWICE to continue WITHOUT MODIFICATION. The primary endpoint the CD12 is mortality.
At the 50% enrollment review, the DSMB asked that an additional review be conducted at 75%/293 participant enrollment. The only logical reason for this additional review is that leronlimab very nearly met the threshold statistical signicance at the 50% review to stop the trial early of overwhelming success. Were the interim results very poor, the DSMB would have argue for trial stoppage, as recently happen to Mesoblast, or increased the trial size if the results were positive but weak, as happened to Humanigen with a 56% increase in trial size after its DSMB review.
The 75%/293 review was to have been conducted weeks ago, but with a rapid increase in the pace of enrollment, the trial is now fully enrolled, with the last patient enrolled December 15.
https://www.cytodyn.com/investors/news-events...strational
CytoDyn Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19
Cytodyn "announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available."
So, I ask that you help me an fellow investors by providing any information you have the demonstrates that this trial will be a flop. Our welfare, and the lives of millions of patients who may be treated with leronlimab, depend on knowing the truth about leronlimab.
Thank you in advance for any concrete information of sources to which you can direct me.
Stay safe and be well.
I know it is a bit off topic, but he has garnered a bit of attention and created a bit of frustration among some of us.
If you don't venture to IHub, my recommendation is not to start. It's a bit unhealthy.
Jusdafacts,
Can you please let me know who "we" are and how you "know CD12 will be a flop?
"Now, now, now, Jerome...we all know CD12 will be a flop therefore will not be supportive of an EUA. "
I believe it presumptuous to argue that we all know this. There is a different between knowing and believing.
An outstanding book to help us appreciate the difference is "On Being Certain: Believing You Are Right Even When You Are Not", by Dr. Richard A. Burton, a neurologist at the University of California San Francisco. It has helped me differentiate between the feeling of certainty and objective knowledge.
I'm for the digression if this does not prove useful to you.
I have been carefully following the bits of available information from both the CD10 leronlimab trial and the DSMB actions during the course of the CD12 trial.
Please correct any factual errors in my assessment that you are able to identify. I appreciate that you and I likely have different interpretations of Cytodyn's prospects, but I am trying to determine the facts of the clinical and regulatory development of leronlimab.
Our beliefs about the future of Cytodyn are obviously each our own, and that we may not appreciate the actual facts of Cytodyn's clinical, regulatory and business development.
CD10, the trial for leronlimab in mild to moderate Covid-19 enrolled 75 patients with a SUBJECTIVE primary endpoint of change in symptom score, assessing fever, myalgia, dyspnea and cough.
You have quite appropriately noted that CD10 failed to demonstrate clinical significance in this endpoint, as the vast majority of patients, both those treated with leronlimab and placebo, recovered quickly (Thankfully for the patients).
However, the secondary endpoints measured a number of OBJECTIVE criteria predictive of worsening clinical condition. Leronlimab demonstrated statistically significant improvement in NEWS2, the National Early Warning Score 2, which measures important clinical signs:
respiration rate
oxygen saturation
supplemental oxygen
temperature
systolic blood pressure
heart rate
level of consciousness
The leronlimab group had a 50% improvement in NEWS2 scores versus 20% in placebo.
In addition to these measurements, the SAFETY of leronlimab was tracked, with a 62% reduction in serious adverse events in the group receiving leronlimab.
In essence, leronlimab was demonstrated to be SAFER than water.
Granted, this was only a phase 2 trial in mild to moderate patients. These results were effectively met with a yawn by the FDA, despite their being markedly better than the time to clinical improvement results upon which remdesivir was approved.
The Cytodyn CD12 trial, as we all know, is nearly complete.
This trial has been reviewed twice by the DSMB, being authorized TWICE to continue WITHOUT MODIFICATION. The primary endpoint the CD12 is mortality.
At the 50% enrollment review, the DSMB asked that an additional review be conducted at 75%/293 participant enrollment. The only logical reason for this additional review is that leronlimab very nearly met the threshold statistical signicance at the 50% review to stop the trial early of overwhelming success. Were the interim results very poor, the DSMB would have argue for trial stoppage, as recently happen to Mesoblast, or increased the trial size if the results were positive but weak, as happened to Humanigen with a 56% increase in trial size after its DSMB review.
The 75%/293 review was to have been conducted weeks ago, but with a rapid increase in the pace of enrollment, the trial is now fully enrolled, with the last patient enrolled December 15.
https://www.cytodyn.com/investors/news-events...strational
CytoDyn Completes Enrollment for Phase 3 Registrational Trial for 390 Patients with Severe-to-Critical COVID-19
Cytodyn "announced today it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients were enrolled and completed a 42-day post-enrollment period. The Company has concluded it will be far more time efficient to forego the second interim analysis and to analyze the data on 390 patients and to provide final data to the U.S. Food and Drug Administration, Health Canada, U.K.’s MHRA, and Philippines FDA, as soon as it is available."
So, I ask that you help me an fellow investors by providing any information you have the demonstrates that this trial will be a flop. Our welfare, and the lives of millions of patients who may be treated with leronlimab, depend on knowing the truth about leronlimab.
Thank you in advance for any concrete information of sources to which you can direct me.
Stay safe and be well.
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