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Posted On: 02/14/2021 2:15:40 AM
Post# of 148871
Re: ClosetInvestor #77813
CI you presented, in a very thorough way, the case for leronlimab to be used early in covid-19 in the mild/moderate population. I've been thinking about this also, considering it would keep tens of thousands of people out of the hospital and would also be a huge market for Cytodyn. But we differ on the utility of using the Incelledix index to identify those who are likely to progress, despite the elegance of the science that informs it.
The way I see it, the turnaround time for the test means there will be some delay in treating people early in their disease progression. Getting that test means another layer or two of lab work and bureaucracy and time between testing positive and getting Leronlimab in the body as early as possible, where it can get to work with as little viral load and immune dysfunction as possible.
I think the general process developed for the REGN and Lilly mabs would work fine for Leronlimab. In other words, if you test positive, are over 65 and/or have comorbidities, call the clinic, talk with a provider, and arrange to drive over and get your first shot. Could be done in your car or the clinic. Get a pulse oximeter and a thermometer and keep track of your symptoms at home, and check in with the clinic in a couple-three days. Let leronlimab do its thing and stay out of the hospital, unless your symptoms worsen. And if you are younger and in relatively good health, but your symptoms worsen and your oxygen levels drop down to the lower 90s then you also call the clinic and arrange for a shot. Hospitals get back to normal, society for the most part gets back to normal...
That process doesn't work well for the Big Pharma mabs because, as most here know, they require intravenous administration at a time when covid patients are at their most contagious. Compared to an injectable, this requires a longer visit to a hospital or special clinics that are few in number... which to some degree defeats the purpose of a drug that is supposed to keep you out of the hospital.
Along with the hurdle of getting approved for M/M patients through EUA or approval, and convincing the medical establishment to use it in this population, the big problem with this vision boils down, of course, to manufacturing! Until that gets resolved the priority will be to use leronlimab for critical patients and that's the proper use of a limited, life-saving resource. But if the mutations prove disruptive and the pandemic stretches deep into this year or next there will be tremendous pressure, here and abroad, to ramp up production for M/M as well as S/C. I think we are kind of discounting worldwide demand, with worldwide bio-reactor capabilities called into play, if leronlimab aces the CD12 test. Just a feeling... (did I say justa?) but I think nations will be offering Cytodyn manufacturing capability in return for a cut of production. What far-thinking Minister of Health, or Pharma/Biotech CEO for that matter, wouldn't want to make that deal? Merck and Novartis and I believe Sanofi all recently agreed to help manufacture other companies vaccines. Why not therapeutics for Cytodyn?
Well CI, can you see my point? Perhaps you disagree, I'm curious.
* * * *
As far as the Incellidix Severity Index goes, I'm sure it will prove invaluable for long haulers and in a hospital setting. Of course I might be wrong here, maybe the turnaround time can be speeded up and the index will become a standard diagnostic tool. But seeing the problems here in the US with testing and vaccine rollout give me concern that any logistical delay in the rapid deployment of a therapeutic is a real problem when the utility of that therapeutic is based on timeliness.
* * * *
Off topic a bit, but I grew up in Belmont, California, a suburb directly north of San Carlos on the Peninsula, where Incellidix is headquartered. Small world.
The way I see it, the turnaround time for the test means there will be some delay in treating people early in their disease progression. Getting that test means another layer or two of lab work and bureaucracy and time between testing positive and getting Leronlimab in the body as early as possible, where it can get to work with as little viral load and immune dysfunction as possible.
I think the general process developed for the REGN and Lilly mabs would work fine for Leronlimab. In other words, if you test positive, are over 65 and/or have comorbidities, call the clinic, talk with a provider, and arrange to drive over and get your first shot. Could be done in your car or the clinic. Get a pulse oximeter and a thermometer and keep track of your symptoms at home, and check in with the clinic in a couple-three days. Let leronlimab do its thing and stay out of the hospital, unless your symptoms worsen. And if you are younger and in relatively good health, but your symptoms worsen and your oxygen levels drop down to the lower 90s then you also call the clinic and arrange for a shot. Hospitals get back to normal, society for the most part gets back to normal...
That process doesn't work well for the Big Pharma mabs because, as most here know, they require intravenous administration at a time when covid patients are at their most contagious. Compared to an injectable, this requires a longer visit to a hospital or special clinics that are few in number... which to some degree defeats the purpose of a drug that is supposed to keep you out of the hospital.
Along with the hurdle of getting approved for M/M patients through EUA or approval, and convincing the medical establishment to use it in this population, the big problem with this vision boils down, of course, to manufacturing! Until that gets resolved the priority will be to use leronlimab for critical patients and that's the proper use of a limited, life-saving resource. But if the mutations prove disruptive and the pandemic stretches deep into this year or next there will be tremendous pressure, here and abroad, to ramp up production for M/M as well as S/C. I think we are kind of discounting worldwide demand, with worldwide bio-reactor capabilities called into play, if leronlimab aces the CD12 test. Just a feeling... (did I say justa?) but I think nations will be offering Cytodyn manufacturing capability in return for a cut of production. What far-thinking Minister of Health, or Pharma/Biotech CEO for that matter, wouldn't want to make that deal? Merck and Novartis and I believe Sanofi all recently agreed to help manufacture other companies vaccines. Why not therapeutics for Cytodyn?
Well CI, can you see my point? Perhaps you disagree, I'm curious.
* * * *
As far as the Incellidix Severity Index goes, I'm sure it will prove invaluable for long haulers and in a hospital setting. Of course I might be wrong here, maybe the turnaround time can be speeded up and the index will become a standard diagnostic tool. But seeing the problems here in the US with testing and vaccine rollout give me concern that any logistical delay in the rapid deployment of a therapeutic is a real problem when the utility of that therapeutic is based on timeliness.
* * * *
Off topic a bit, but I grew up in Belmont, California, a suburb directly north of San Carlos on the Peninsula, where Incellidix is headquartered. Small world.
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