This is what happened to the EUA request for mild/moderate from the FDA in my opinion.
Pourhassen went to the FDA and told them he was going to make the request. The FDA said he was not going to get an EUA for M/M. Why? BECAUSE OF SUPPLY!
The FDA spoke clearly - the sickest come first! There were two reasons - their goal is to take dying off the table as quick as possible so the economy can begin to open up again; second, the limited supply of Leronlimab was not to be used up on patients who were not that sick.
This is, reading between the lines, great news - the FDA believes Leronlimab could be the therapy that takes death off the table and that such a valuable resource can not be sqandered on those who are less sick.
It is evident to me that supply is still Cytodyn and Leronlimab's biggest stumbling block. It was one of the first things asked about by the UK. They, to their credit, said they would help with funds for manufacture. However, no one can supply us with extra time to make the quantities needed if approved!
How much Leronlimab is available? You can't sell and supply what you DON'T HAVE! Some people here have said, "Well, we wouldn't have severe/critical cases if mild/moderates were given Leronlimab." They really don't get it!
The maximum Leronlimab available now is unknown but small. The max by the end of the year is 1.3 million vials maybe. At a minimum of 4 vials per treatment an now prescribed, that allows us to treat a little over 300,000 patients. That might cover severe/critical by the end of the year in the US but what about the UK and the rest of the world?
Supply and visibility are still Cytodyn's biggest problems, assuming with visibility comes funds and the political power to "jump the line" at limited production facilities.
This is how I see things. Cytodyn, being so small and all thing considered, has done a pretty good job in evolving emergency times of the pandemic and is not neglecting the promise of efficacy for other indications. They have my respect!
Pourhassen went to the FDA and told them he was going to make the request. The FDA said he was not going to get an EUA for M/M. Why? BECAUSE OF SUPPLY!
The FDA spoke clearly - the sickest come first! There were two reasons - their goal is to take dying off the table as quick as possible so the economy can begin to open up again; second, the limited supply of Leronlimab was not to be used up on patients who were not that sick.
This is, reading between the lines, great news - the FDA believes Leronlimab could be the therapy that takes death off the table and that such a valuable resource can not be sqandered on those who are less sick.
It is evident to me that supply is still Cytodyn and Leronlimab's biggest stumbling block. It was one of the first things asked about by the UK. They, to their credit, said they would help with funds for manufacture. However, no one can supply us with extra time to make the quantities needed if approved!
How much Leronlimab is available? You can't sell and supply what you DON'T HAVE! Some people here have said, "Well, we wouldn't have severe/critical cases if mild/moderates were given Leronlimab." They really don't get it!
The maximum Leronlimab available now is unknown but small. The max by the end of the year is 1.3 million vials maybe. At a minimum of 4 vials per treatment an now prescribed, that allows us to treat a little over 300,000 patients. That might cover severe/critical by the end of the year in the US but what about the UK and the rest of the world?
Supply and visibility are still Cytodyn's biggest problems, assuming with visibility comes funds and the political power to "jump the line" at limited production facilities.
This is how I see things. Cytodyn, being so small and all thing considered, has done a pretty good job in evolving emergency times of the pandemic and is not neglecting the promise of efficacy for other indications. They have my respect!
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