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Posted On: 05/25/2021 5:27:41 PM
Post# of 148899
It would seem CytoDyn has still not learned how to design a bulletproof protocol -- even in the face of repeated and embarrassing failures.
First of all, neither of these trial are described as "Adaptive Design". Why not?
Moving on, we all know the over/under 65 results from the CD12. Why isn't the Critical protocol optimized to target the cohort we know we can win an approval with?
Do we think they've even included age matching protocols this time around? I somehow doubt it.
And the Moderate protocol -- stop me before I start using foul language.
Really, 350mg? No dose escalation? Who came up with this brilliant idea? Were they just sitting around, trying to figure out how they could handicap and fail another trial?
There isn't a single leronlimab indication that is not improved through the administration of the 700mg dose. There's no reason on earth to design a trial using 350mg -- unless your goal is complete and utter failure. Even the LH trial (which may be characterized as a different disease -- or disease stage) uses 8-consecutive doses of 700mg.
This is clearly not the time to perform cost-benefit trials to determine minimum effective dosages. It is the time to prove to the world, once and for all, that the molecule works at the optimum dose and the optimum frequency -- which we did not do with the CD10.
What exactly is wrong with our team? Do they not understand that we are in "Hail Mary" mode -- and there is absolutely no room for failure?
These morons are going to waste millions of our dollars treating 594 patients with inadequate dosing. Even a child could understand this. I expect the Moderate trial will fail -- just as I expressed concern last July that we'd possibly fail the CD12 due to the 2-dose limitation.
Many of you will remember accusing me as being a short when I expressed that concern. Of course, I'm sure you've now conveniently forgotten your baseless accusations. Isn't human nature wonderful?
It's no wonder a group has formed that wants to remove current management.
First of all, neither of these trial are described as "Adaptive Design". Why not?
Moving on, we all know the over/under 65 results from the CD12. Why isn't the Critical protocol optimized to target the cohort we know we can win an approval with?
Do we think they've even included age matching protocols this time around? I somehow doubt it.
And the Moderate protocol -- stop me before I start using foul language.
Really, 350mg? No dose escalation? Who came up with this brilliant idea? Were they just sitting around, trying to figure out how they could handicap and fail another trial?
There isn't a single leronlimab indication that is not improved through the administration of the 700mg dose. There's no reason on earth to design a trial using 350mg -- unless your goal is complete and utter failure. Even the LH trial (which may be characterized as a different disease -- or disease stage) uses 8-consecutive doses of 700mg.
This is clearly not the time to perform cost-benefit trials to determine minimum effective dosages. It is the time to prove to the world, once and for all, that the molecule works at the optimum dose and the optimum frequency -- which we did not do with the CD10.
What exactly is wrong with our team? Do they not understand that we are in "Hail Mary" mode -- and there is absolutely no room for failure?
These morons are going to waste millions of our dollars treating 594 patients with inadequate dosing. Even a child could understand this. I expect the Moderate trial will fail -- just as I expressed concern last July that we'd possibly fail the CD12 due to the 2-dose limitation.
Many of you will remember accusing me as being a short when I expressed that concern. Of course, I'm sure you've now conveniently forgotten your baseless accusations. Isn't human nature wonderful?
It's no wonder a group has formed that wants to remove current management.
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