The day after the CD12 trial results were released in an 8-K, I posted msg 82408 -
I hesitate to bring this up but does anyone else find the trial numbers suspicious?
Looking at them, I come to them with the conviction that I stated in msg 81679 - "Make no mistake - all recipients of Leronlimab benefited to some degree, even the ones too far gone to survive!" Not all of the trial patients were in the ICU because of Cytokine Storm but I know that Leronlimab shut down RANTES in everyone who got it! By some metric, Leronlimab helped everyone!
So why aren't we seeing the results we were expecting to see in these CD12 numbers? I'm not talking about primary and secondary endpoints and p values. I was expecting to see the result we saw from the first uses of Leronlimab with Seethamraju, Lang, Agresti and Reknor. Sure SOC has gotten better but NEWS type scores, Ordinal Scale numbers should have been better, much better in my opinion.
We had some large improvement by some individuals so of course the Ordinal Scale numbers would go up but if the numbers of all patients who got Leronlimab went up, we should see these number much higher. What happened to individual patients is lost in the average totals reported in the 8K report.
If something suspicious was going on, it would have shown itself in the individual cases where, after injection with Leronlimab, there was no patient improvement at all. We may not have used the metrics in the trial to show this but that result would have been there. Blood tests would have been nice but just the clinical outcomes should have been obvious.
This issue really worries me because if something funny went on with the CD12 trials, it could go funny with this CD16 trial. What are the checks and balances? Are we totally sure that those who were supposed to get Leronlimab really did get Leronlimab?
Can we compare the Ordinal (NEWS) type scores of those who got Leronlimab thru OLE and eINDs with those in the CD12 trial? Can we insist on blood tests after Leronlimab administration in the CD16 trial? We can't afford any screw-ups!
The numbers got me a little paranoid and even conspiratorial at the end of that post but I wasn't wrong about the numbers in the 8-K being way off. I even PMed another IH member -
I'm still disturbed by the CD12 results and Leronlimab's seeming lack of efficacy. So can I float a hypothetical to you, tho it may be far fetched?
How would the trial have been effected if the batches of LL and placebo had been mixed up to 50-50 ratio instead of 2 to 1?
As far as I know, there was no check or balance to prevent that from happening, like blood tests that even Melon Toy talked about for CD10. There may have been blood tests but no one has mentioned them. Wouldn't someone mention them if they saw blood numbers changing for some trial patients as much as they did for Melon Toy?
The Exec Summary numbers just don't make sense to me. The lack of differential in the Ordinal Scale numbers just don't ring true to me.
But I would like to know how you think my hypothetical would have changed result, all other things being the same.
Thanks,
- CX
Now the reason for the suspicious numbers is hopefully becoming clearer and we can move ahead quickly and correctly. There is still fine tuning to be done on dosing and timing which has also bugged me for a long time. I would still like to see the CD12 patient data gone over with a fine-toothed comb. The truth is in the data as we are only now seeing proven!
Sorry for the long post.
I hesitate to bring this up but does anyone else find the trial numbers suspicious?
Looking at them, I come to them with the conviction that I stated in msg 81679 - "Make no mistake - all recipients of Leronlimab benefited to some degree, even the ones too far gone to survive!" Not all of the trial patients were in the ICU because of Cytokine Storm but I know that Leronlimab shut down RANTES in everyone who got it! By some metric, Leronlimab helped everyone!
So why aren't we seeing the results we were expecting to see in these CD12 numbers? I'm not talking about primary and secondary endpoints and p values. I was expecting to see the result we saw from the first uses of Leronlimab with Seethamraju, Lang, Agresti and Reknor. Sure SOC has gotten better but NEWS type scores, Ordinal Scale numbers should have been better, much better in my opinion.
We had some large improvement by some individuals so of course the Ordinal Scale numbers would go up but if the numbers of all patients who got Leronlimab went up, we should see these number much higher. What happened to individual patients is lost in the average totals reported in the 8K report.
If something suspicious was going on, it would have shown itself in the individual cases where, after injection with Leronlimab, there was no patient improvement at all. We may not have used the metrics in the trial to show this but that result would have been there. Blood tests would have been nice but just the clinical outcomes should have been obvious.
This issue really worries me because if something funny went on with the CD12 trials, it could go funny with this CD16 trial. What are the checks and balances? Are we totally sure that those who were supposed to get Leronlimab really did get Leronlimab?
Can we compare the Ordinal (NEWS) type scores of those who got Leronlimab thru OLE and eINDs with those in the CD12 trial? Can we insist on blood tests after Leronlimab administration in the CD16 trial? We can't afford any screw-ups!
The numbers got me a little paranoid and even conspiratorial at the end of that post but I wasn't wrong about the numbers in the 8-K being way off. I even PMed another IH member -
I'm still disturbed by the CD12 results and Leronlimab's seeming lack of efficacy. So can I float a hypothetical to you, tho it may be far fetched?
How would the trial have been effected if the batches of LL and placebo had been mixed up to 50-50 ratio instead of 2 to 1?
As far as I know, there was no check or balance to prevent that from happening, like blood tests that even Melon Toy talked about for CD10. There may have been blood tests but no one has mentioned them. Wouldn't someone mention them if they saw blood numbers changing for some trial patients as much as they did for Melon Toy?
The Exec Summary numbers just don't make sense to me. The lack of differential in the Ordinal Scale numbers just don't ring true to me.
But I would like to know how you think my hypothetical would have changed result, all other things being the same.
Thanks,
- CX
Now the reason for the suspicious numbers is hopefully becoming clearer and we can move ahead quickly and correctly. There is still fine tuning to be done on dosing and timing which has also bugged me for a long time. I would still like to see the CD12 patient data gone over with a fine-toothed comb. The truth is in the data as we are only now seeing proven!
Sorry for the long post.
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