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Posted On: 12/18/2023 3:39:46 PM
Post# of 148863
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https://www.reddit.com/r/Livimmune/comments/1...anagement/
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1 hr. ago
Beldar2
Suggestion for CYDY management
After the last call and the pivot towards immunomodulation I too (like MGK) have been thinking about the overlaps of clinical results from the various indications and the effect that Leronlimab has had on all biomarkers not just cytokines; however, I don’t have the bandwidth to pull it all together. I assume that management has collected a database of detailed bioinformatics and outcomes on every individual trial participant (in conformance with HIPAA) and that the audit of Amarex data resulted in a high degree of data accuracy that allows it to join all the other data in this database. Everything that all the clinicians captured at pre-treatment, at defined trial intervals, at open extension intervals and post-treatment visits should have made it into this database. All the HIV data, all the oncology data, all the NASH data and maybe even all the COVID data from Dr. Bruce's lab. I might be wrong but I have a distant recollection that at some point Dr. Bruce said he would make available the detailed data that supported the development of his diagnostic cytokine storm ratio patent application. Who knows, maybe Dr. Bruce can be convinced to contribute all his Leronlimab related treatment data for the betterment of mankind.
This is a playground for biostatisticians. But like a child running into a playground and bouncing from the seesaw to the swings to the slide, it could be a tremendous burn of energy. Focus came in the form of the pivot and the protocol for the next trial. HIV and the controlled analysis of Leronlimab's impact on cytokines would be the trial's primary outcome measures. Secondary measures, or more likely, predefined analysis could include the coincidental effect on cytokines brought on in other trials for other indications like NASH. The bigger picture of all CYDY data shows Leronlimab's impact on cytokines under a variety of diseases, disease states and the biodiversity of the patients involved.
While the runway is short and funds limited, the HIV trial does not have to be the only focus. Bring in Absci (or its equivalent as an analytics partner). Rather than conduct another trial and incur the Hundreds of Million$ required, the analytics partner can be unleashed against this data trove to provide multiple provocative insights with statistical certainty. The data science necessary to underpin the proper statistical analysis is not without a cost but it must must be done to ensure "apples to apples" and that no garbage goes in so that no garbage comes out.
Dr. Jay said there is provocative data that the world has yet to see. The output of the analytics partner is not ad hoc as ad hoc is sometimes considered in the pejorative if it were in a clinical trial setting. It would be new and freshly minted findings that support Leronlimab’s MOA and/or potential impact on cytokines. How would you make this new information available? Some information of a proprietary nature should not be released but much of it could possibly be. To peer review or not peer review that is the question. I suggest that CYDY and its analytics partner develop a joint communications strategy along with a process to efficiently translate “releasable” provocative findings backed by statistical certainty into press releases. Confirm that the data has been properly audited. Most of it already has been as part of trial database locks. Use standard statistical methods. Have each press release relay that the information is not peer reviewed but is sourced from an audited source and summarize the statistical methods used. This new and more open communications policy will create a buzz that builds anticipation for peer reviewed information releases and be a win for the analytics partner, a win for CYDY and a win for shareholders.
https://www.reddit.com/r/Livimmune/comments/1...anagement/
Go to Livimmune
r/Livimmune
•
1 hr. ago
Beldar2
Suggestion for CYDY management
After the last call and the pivot towards immunomodulation I too (like MGK) have been thinking about the overlaps of clinical results from the various indications and the effect that Leronlimab has had on all biomarkers not just cytokines; however, I don’t have the bandwidth to pull it all together. I assume that management has collected a database of detailed bioinformatics and outcomes on every individual trial participant (in conformance with HIPAA) and that the audit of Amarex data resulted in a high degree of data accuracy that allows it to join all the other data in this database. Everything that all the clinicians captured at pre-treatment, at defined trial intervals, at open extension intervals and post-treatment visits should have made it into this database. All the HIV data, all the oncology data, all the NASH data and maybe even all the COVID data from Dr. Bruce's lab. I might be wrong but I have a distant recollection that at some point Dr. Bruce said he would make available the detailed data that supported the development of his diagnostic cytokine storm ratio patent application. Who knows, maybe Dr. Bruce can be convinced to contribute all his Leronlimab related treatment data for the betterment of mankind.
This is a playground for biostatisticians. But like a child running into a playground and bouncing from the seesaw to the swings to the slide, it could be a tremendous burn of energy. Focus came in the form of the pivot and the protocol for the next trial. HIV and the controlled analysis of Leronlimab's impact on cytokines would be the trial's primary outcome measures. Secondary measures, or more likely, predefined analysis could include the coincidental effect on cytokines brought on in other trials for other indications like NASH. The bigger picture of all CYDY data shows Leronlimab's impact on cytokines under a variety of diseases, disease states and the biodiversity of the patients involved.
While the runway is short and funds limited, the HIV trial does not have to be the only focus. Bring in Absci (or its equivalent as an analytics partner). Rather than conduct another trial and incur the Hundreds of Million$ required, the analytics partner can be unleashed against this data trove to provide multiple provocative insights with statistical certainty. The data science necessary to underpin the proper statistical analysis is not without a cost but it must must be done to ensure "apples to apples" and that no garbage goes in so that no garbage comes out.
Dr. Jay said there is provocative data that the world has yet to see. The output of the analytics partner is not ad hoc as ad hoc is sometimes considered in the pejorative if it were in a clinical trial setting. It would be new and freshly minted findings that support Leronlimab’s MOA and/or potential impact on cytokines. How would you make this new information available? Some information of a proprietary nature should not be released but much of it could possibly be. To peer review or not peer review that is the question. I suggest that CYDY and its analytics partner develop a joint communications strategy along with a process to efficiently translate “releasable” provocative findings backed by statistical certainty into press releases. Confirm that the data has been properly audited. Most of it already has been as part of trial database locks. Use standard statistical methods. Have each press release relay that the information is not peer reviewed but is sourced from an audited source and summarize the statistical methods used. This new and more open communications policy will create a buzz that builds anticipation for peer reviewed information releases and be a win for the analytics partner, a win for CYDY and a win for shareholders.
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