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Posted On: 05/26/2021 3:04:07 PM
Post# of 148899
@ OldGandalf
@ 2MartiniGi
Thank you both for your valid points.
The bigger question is: At this point in time, why is CytoDyn allowing ANY entity to halve the known effective dosage?
The CD10 and CD12 were both severely handicapped due to the administration of only 2-weekly doses during a 4-week trial. In what universe did that make sense – especially during a deadly pandemic? This fact has given me daily heartburn for 11 months.
I personally don’t subscribe to the excuse that it was early in the pandemic. Hundreds of thousands were dying -- it was a 4-week trial -- you give them the therapy for 4-weeks – end of story.
Now, we could sit around all day long blaming the FDA, CytoDyn, or Big Pharma for not addressing this glaringly obvious shortcoming – but we’d just be wasting our time.
Bottom Line: We failed.
Press the FF button and we are now in May. The company is running on (toxic) financial fumes and we are desperately trying to rectify past mistakes.
And now we are told that an expensive and time-consuming trial -- that must succeed because failure is not an option -- is being conducted with an untested half-dose of 350mg?
Someone please tell me why an untested, halved dose is being used in a Phase 3 trial? That is not what you do in a P3.
There is no way that a 350mg dose is going to be as effective as a 700mg dose. We've seen this play out over-and-over. The molecule has nearly no SAEs – so give them the full dose that we know worked to a limited degree (NEWS2) in the CD10.
Let’s recap: We failed our first trials due to the dose frequency being halved – so now, our brilliant solution is to halve 3 of the 4 doses in the second trial? WTF.
This is clearly not the time for exploratory trials that are intended to distill the absolute minimum effective dosages. This is the time to get it right with the dose that we know worked to a limited degree.
This trial hasn’t even begun and we’re already making excuses that this new protocol blunder might be once again caused by the FDA, Big Pharma or the AE Hospital.
I’m having a very hard time believing that CytoDyn is a powerless pawn in this equation – the second time around. And that they are this powerless in another country -- outside of the direct grip of the FDA? If that’s the case, then don’t waste millions of dollars doing that trial in Brazil.
Frankly, my bigger concern is that if the company is this really powerless, and they don't know how to navigate regulatory bodies or even a Brazilian hospital -- then they clearly don't have the experience to be the master of their own destiny – and our destiny as well.
I want this company and this molecule to succeed.
@ 2MartiniGi
Thank you both for your valid points.
The bigger question is: At this point in time, why is CytoDyn allowing ANY entity to halve the known effective dosage?
The CD10 and CD12 were both severely handicapped due to the administration of only 2-weekly doses during a 4-week trial. In what universe did that make sense – especially during a deadly pandemic? This fact has given me daily heartburn for 11 months.
I personally don’t subscribe to the excuse that it was early in the pandemic. Hundreds of thousands were dying -- it was a 4-week trial -- you give them the therapy for 4-weeks – end of story.
Now, we could sit around all day long blaming the FDA, CytoDyn, or Big Pharma for not addressing this glaringly obvious shortcoming – but we’d just be wasting our time.
Bottom Line: We failed.
Press the FF button and we are now in May. The company is running on (toxic) financial fumes and we are desperately trying to rectify past mistakes.
And now we are told that an expensive and time-consuming trial -- that must succeed because failure is not an option -- is being conducted with an untested half-dose of 350mg?
Someone please tell me why an untested, halved dose is being used in a Phase 3 trial? That is not what you do in a P3.
There is no way that a 350mg dose is going to be as effective as a 700mg dose. We've seen this play out over-and-over. The molecule has nearly no SAEs – so give them the full dose that we know worked to a limited degree (NEWS2) in the CD10.
Let’s recap: We failed our first trials due to the dose frequency being halved – so now, our brilliant solution is to halve 3 of the 4 doses in the second trial? WTF.
This is clearly not the time for exploratory trials that are intended to distill the absolute minimum effective dosages. This is the time to get it right with the dose that we know worked to a limited degree.
This trial hasn’t even begun and we’re already making excuses that this new protocol blunder might be once again caused by the FDA, Big Pharma or the AE Hospital.
I’m having a very hard time believing that CytoDyn is a powerless pawn in this equation – the second time around. And that they are this powerless in another country -- outside of the direct grip of the FDA? If that’s the case, then don’t waste millions of dollars doing that trial in Brazil.
Frankly, my bigger concern is that if the company is this really powerless, and they don't know how to navigate regulatory bodies or even a Brazilian hospital -- then they clearly don't have the experience to be the master of their own destiny – and our destiny as well.
I want this company and this molecule to succeed.
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