You are right, the docs will just use it for severe/critical if approved for mild/moderate (or vice versa).
But at least at first, the doctors simply will not have that choice due to limited supply of leronlimab.
Even if Samsung delivers perfectly, 125,000 vials for 30,000 patients in early July, that is simply not enough for any covid patient group.
Someone will have to ration the supply of leronlimab for the first couple months at least.
So the docs won't get the choice of using for the unapproved.
The best way to ration leronlimab is to approve it for severe/critical only. The FDA could probably come up with some triage-like strategy for only dosing the sickest patients first.
And this could be quite challenging for the FDA if a couple of patients die in the severe/critical leronlimab arm of the servere/critical trial. Maybe the statistics say that leronlimab worked in mild/moderate but not in severe/critical. There are only 50 patients in the severe/critical so random mortality events can easily completely swamp out the statistical significance of leronlimab.
The mild/moderate trial, on the other hand, has quantitative sliding scales for all of the relative endpoints so i would guess the mild/moderate trial is less susceptible to non-representative events messing with the statistics.
So i suspect that if mild/moderate passes the p-value test, and severe/critical is anywhere in the ballpark, then the FDA will choose to ration by approving severe/critical only until the leronlimab supply comes up.
All of CYDY, the FDA, and the government face very serious challenges in the event of leronlimab covid success.
And that is likely the reason for radio silence this week from CYDY. There is certainly no more need for youtube videos. CYDY workers will need all the time they can get to plan for the chaos that could result from FDA covid approval.
Perhaps someone will get all of CYDY, the FDA, and federal government on the same page. Better to work towards that then youtube videos.
CYDY also has to get its own unique business issues straightened out, like uplisting and a financing, whether from sale of the first Samsung shipment or a secondary offering.
Seems to me CYDY has zero time for further youtube videos.
But at least at first, the doctors simply will not have that choice due to limited supply of leronlimab.
Even if Samsung delivers perfectly, 125,000 vials for 30,000 patients in early July, that is simply not enough for any covid patient group.
Someone will have to ration the supply of leronlimab for the first couple months at least.
So the docs won't get the choice of using for the unapproved.
The best way to ration leronlimab is to approve it for severe/critical only. The FDA could probably come up with some triage-like strategy for only dosing the sickest patients first.
And this could be quite challenging for the FDA if a couple of patients die in the severe/critical leronlimab arm of the servere/critical trial. Maybe the statistics say that leronlimab worked in mild/moderate but not in severe/critical. There are only 50 patients in the severe/critical so random mortality events can easily completely swamp out the statistical significance of leronlimab.
The mild/moderate trial, on the other hand, has quantitative sliding scales for all of the relative endpoints so i would guess the mild/moderate trial is less susceptible to non-representative events messing with the statistics.
So i suspect that if mild/moderate passes the p-value test, and severe/critical is anywhere in the ballpark, then the FDA will choose to ration by approving severe/critical only until the leronlimab supply comes up.
All of CYDY, the FDA, and the government face very serious challenges in the event of leronlimab covid success.
And that is likely the reason for radio silence this week from CYDY. There is certainly no more need for youtube videos. CYDY workers will need all the time they can get to plan for the chaos that could result from FDA covid approval.
Perhaps someone will get all of CYDY, the FDA, and federal government on the same page. Better to work towards that then youtube videos.
CYDY also has to get its own unique business issues straightened out, like uplisting and a financing, whether from sale of the first Samsung shipment or a secondary offering.
Seems to me CYDY has zero time for further youtube videos.
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