The possibility that intravenous dosing of covid patients could be massively important has been plainly obvious for months.
At the moment you ascribe leronlimab's MOA to immune cell migration modulation by CCR5 blockade, it is obvious, totally and completely obvious, that emergency covid patients might benefit tremendously from an intravenous rather than subcutaneous infustion.
So why has no covid patient ever been dosed intravenously?
Another obvious point is that the CyDy management team is simply too inexperienced to navigate this problem. CYDY has now taken ten months to complete a trial in the middle of a pandemic. CYDY struggled to do any trial, let alone a trial with a different kind of dose.
Maybe its true that the transition from human trials with subcutaneous delivery to intravenous delivery takes a long time. Maybe the FDA just won't let you take any shortcuts here. Maybe you have to run a phase 3 with another 390 patients with intravenous dosing.
But I doubt it. I expect there is a fast way to examine intravenous dosing in the middle of a pandemic.
Why didn't Cytodyn make an effort for intravenous dosing? Lalezari certainly tried to increase the subcutaneous dose, but he was stopped cold.
Maybe Cytodyn didn't understand the importance of receptor occupancy in treatment of covid? Cytodyn certainly didn't think RO testing was important enough to work out their problems with Patterson.
Probably Patterson deserves some blame for deficiencies in leronlimab covid trials, not only as to the absence of intravenous dosing but also the possible lack of RO testing in CD12.
Patterson knew from the very beginning that RO was pivotal in achieving the immunomodulatory effects of leronlimab.
Because Patterson understood earlier than everyone else the possible importance of RO in covid, he also no doubt understood the possible importance of IV dosing in emergent patients.
But why no push for intravenous dosing from Patterson?
Maybe he has some data on the day zero and day 3 RO that casts doubt on the importance of 100% receptor occupancy in covid.
At the moment you ascribe leronlimab's MOA to immune cell migration modulation by CCR5 blockade, it is obvious, totally and completely obvious, that emergency covid patients might benefit tremendously from an intravenous rather than subcutaneous infustion.
So why has no covid patient ever been dosed intravenously?
Another obvious point is that the CyDy management team is simply too inexperienced to navigate this problem. CYDY has now taken ten months to complete a trial in the middle of a pandemic. CYDY struggled to do any trial, let alone a trial with a different kind of dose.
Maybe its true that the transition from human trials with subcutaneous delivery to intravenous delivery takes a long time. Maybe the FDA just won't let you take any shortcuts here. Maybe you have to run a phase 3 with another 390 patients with intravenous dosing.
But I doubt it. I expect there is a fast way to examine intravenous dosing in the middle of a pandemic.
Why didn't Cytodyn make an effort for intravenous dosing? Lalezari certainly tried to increase the subcutaneous dose, but he was stopped cold.
Maybe Cytodyn didn't understand the importance of receptor occupancy in treatment of covid? Cytodyn certainly didn't think RO testing was important enough to work out their problems with Patterson.
Probably Patterson deserves some blame for deficiencies in leronlimab covid trials, not only as to the absence of intravenous dosing but also the possible lack of RO testing in CD12.
Patterson knew from the very beginning that RO was pivotal in achieving the immunomodulatory effects of leronlimab.
Because Patterson understood earlier than everyone else the possible importance of RO in covid, he also no doubt understood the possible importance of IV dosing in emergent patients.
But why no push for intravenous dosing from Patterson?
Maybe he has some data on the day zero and day 3 RO that casts doubt on the importance of 100% receptor occupancy in covid.
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