Trding, Yes, there have been few mentions of de
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Posted On: 04/14/2020 9:29:07 AM
Trding,
Yes, there have been few mentions of death rate around. Yesterday I heard in a large cable network the same number. The U.K. is working with a slightly lower one whereas in china the reports printed larger numbers (in some cases up to 90%).
This si important because this is what we will be probably stacked against in our trial (P 2b/3 Severe).
In agreeing with you in regards to the double blinded trial, let me say that it is insane. By now we have enough data to know with very good certainty what the probability of success without Leronlimab is. This can be used for comparison purposes with high accuracy. In this case there is no need for "placebo effect elimination". By Pete's sake, these folks are dying and need help !!!
So, my opinion is simply that FDA should run the Severe trial using this statistics and take a early review as the trial goes along.
As an example, lets asume a probability of success of 20%, meaning that of 50 patients in the past 10 survived. And we treat with Leronlimab 50 patients and 40% survive (to throw a number). This yields a p-number of 0.00093 meaning, beyond statistical doubt, that the drug is helping. The trial should be stopped right there and Leronlimab approved.
As a requisite once this is done, FDA will request from CYDY to continue gathering statistical information (this is quite normal and is almost always done with vaccines, for example).
Now, let's assume that after 50 patients 16 have survived (32%) after the predetermined time period (p=0.0308), FDA can decide to continue the trial for 50 more as the p-number is close to 0.05 and so on. If, at the end, this number is holding (or less than 0.05) Leronlimab will be approved at full trial length (390 patients).
This will achieve two things: use a widely-available statistical basis for the control cohort and put the drug in the market as soon as possible saving lives (apart from those saved by not denying more patients a potentially beneficial drug).
Maybe I am dreaming, but I really don't understand FDA's attitude standing there with close to 2000 people dying every day (only in USA) … and not giving a rational break to a drug proven throughout the years to be safe. Heck there are people taking it for more than 5 years now with no SAEs !!
Just maddening …
Yes, there have been few mentions of death rate around. Yesterday I heard in a large cable network the same number. The U.K. is working with a slightly lower one whereas in china the reports printed larger numbers (in some cases up to 90%).
This si important because this is what we will be probably stacked against in our trial (P 2b/3 Severe).
In agreeing with you in regards to the double blinded trial, let me say that it is insane. By now we have enough data to know with very good certainty what the probability of success without Leronlimab is. This can be used for comparison purposes with high accuracy. In this case there is no need for "placebo effect elimination". By Pete's sake, these folks are dying and need help !!!
So, my opinion is simply that FDA should run the Severe trial using this statistics and take a early review as the trial goes along.
As an example, lets asume a probability of success of 20%, meaning that of 50 patients in the past 10 survived. And we treat with Leronlimab 50 patients and 40% survive (to throw a number). This yields a p-number of 0.00093 meaning, beyond statistical doubt, that the drug is helping. The trial should be stopped right there and Leronlimab approved.
As a requisite once this is done, FDA will request from CYDY to continue gathering statistical information (this is quite normal and is almost always done with vaccines, for example).
Now, let's assume that after 50 patients 16 have survived (32%) after the predetermined time period (p=0.0308), FDA can decide to continue the trial for 50 more as the p-number is close to 0.05 and so on. If, at the end, this number is holding (or less than 0.05) Leronlimab will be approved at full trial length (390 patients).
This will achieve two things: use a widely-available statistical basis for the control cohort and put the drug in the market as soon as possible saving lives (apart from those saved by not denying more patients a potentially beneficial drug).
Maybe I am dreaming, but I really don't understand FDA's attitude standing there with close to 2000 people dying every day (only in USA) … and not giving a rational break to a drug proven throughout the years to be safe. Heck there are people taking it for more than 5 years now with no SAEs !!
Just maddening …
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