I honestly don't think we have to worry much about Cytodyn's future success. People are worrying way too much. Right now, everything is way too FDA-centric. Here is how I see things going.
Cytodyn needs to concentrate on finishing the CD12 Top Line Report as soon as possible. It can then be submitted to the drug authorities in other countries. They do not all work off the same benchmarks as the US FDA and I think they will be more amenable to arguments for Leronlimab's approval or at least EUA.
The Top Line Report can tease out all the nuances in the trial data and make an argument that more clinical considerations should be considered instead of those stupid P values.
The case of every single patient can be gone over with a fine-toothed comb. What treatment did each patient get? Did they get Dexamethasone, an immunosuppressant while they were also getting Leronlimab, an immunity booster? Did severe and critical patients change categories after they were first treated, leaving the Leronlimab arm "underpowered" (less critical patients) because of its success? Was it fair at the end of a trial to separate the benefits to severe patients from those of the critical patients because of an endpoint chosen before anyone knew squat about what caused Covid, almost 12 months ago? Make no mistake - all recipients of Leronlimab benefited to some degree, even the ones too far gone to survive!
The Top Line Report is an argumentative document. It is meant to put the best case forward for the approval of a drug. Cytodyn should do that and give it to the other drug authorities like the MHRA who have already said they are willing to look at out-of-trial data like eIND data and OLE data. It sounds to me like other FDAs are more likely to give approval because of NEWS type standards rather than "P values". More power to them!
Leronlimab works great! Is its treatment benefit to be denied because of trial vagaries? What kind of a world do we live in if it isn't one that is crying out for solutions to the tyranny of this Pandemic?
Sanity will prevail somewhere on this planet if it isn't here in the US with this FDA. Leronlimab and Cytodyn will prevail and thrive. Those who do not enable their forward success will just end up looking stupid.
Cytodyn needs to concentrate on finishing the CD12 Top Line Report as soon as possible. It can then be submitted to the drug authorities in other countries. They do not all work off the same benchmarks as the US FDA and I think they will be more amenable to arguments for Leronlimab's approval or at least EUA.
The Top Line Report can tease out all the nuances in the trial data and make an argument that more clinical considerations should be considered instead of those stupid P values.
The case of every single patient can be gone over with a fine-toothed comb. What treatment did each patient get? Did they get Dexamethasone, an immunosuppressant while they were also getting Leronlimab, an immunity booster? Did severe and critical patients change categories after they were first treated, leaving the Leronlimab arm "underpowered" (less critical patients) because of its success? Was it fair at the end of a trial to separate the benefits to severe patients from those of the critical patients because of an endpoint chosen before anyone knew squat about what caused Covid, almost 12 months ago? Make no mistake - all recipients of Leronlimab benefited to some degree, even the ones too far gone to survive!
The Top Line Report is an argumentative document. It is meant to put the best case forward for the approval of a drug. Cytodyn should do that and give it to the other drug authorities like the MHRA who have already said they are willing to look at out-of-trial data like eIND data and OLE data. It sounds to me like other FDAs are more likely to give approval because of NEWS type standards rather than "P values". More power to them!
Leronlimab works great! Is its treatment benefit to be denied because of trial vagaries? What kind of a world do we live in if it isn't one that is crying out for solutions to the tyranny of this Pandemic?
Sanity will prevail somewhere on this planet if it isn't here in the US with this FDA. Leronlimab and Cytodyn will prevail and thrive. Those who do not enable their forward success will just end up looking stupid.
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