Watching Dr Yo / Dr Patterson....
Points of interest (my paraphrase / interpretation):
Day 3 huge impact for M2M patients over and against placebo reported. If this data holds through the submission of data to FDA, it should be basis for approval. M2M patients can be released earlier, saving $$ and healthcare resources. The M2M patients ALL had symptoms, incl cytokines. All had benefit from leronlimab.
M2M achieved results that no other CV drug has experienced... That is significant. Seems reasonable to expect approval.
Did not measure viral load in M2M samples, not a part of the trial. Not included in the analysis. Would need to run the samples.
Key for drug's success is clinical outcome being aligned with MOA. M2M is showing this, along with supporting EIND experiences. Day 3 is a critical day for proof of immunological improvement. Day 3 is "game time". Establishing credibility.
FDA doesn't have time to do all the study of the MOA science; they want the statistical analysis to drive their decision. Too many other drugs / priorities.
Dr BP's paper to come out "very soon". Became aware of some "political stuff"; addressed it with editors and got it straightened out, or will be doing so. Been fully reviewed now, and awaiting final decision on publication. Dr P says he's reviewed over 100 papers himself, and his paper is solid and WILL be published soon. "It will see the light of day." 15,000 views of preprint have been logged.
Blood samples are coming in from all over the world for testing. (All recognizing the IncellDX work related to leronlimab) Many Drs in U.S. aware of and following leronlimab on social media. Dr Yo said this is due to Dr BP's advocacy and ability to explain the science. How can we get Dr BP out there to do more?
DrBP: What is needed is regulatory recognition / approval, along with published papers, which will ultimately get the word out and create the application of this drug to the need. (Implicit: awareness of the investment opportunity)
Example given: there are many stories of scientific findings ignored by public for years, and then it clicks. "It takes a while for people to get their arms around it." (Dr BP) Just keep talking about it. It needs to percolate over time. Some companies don't have big marketing teams to push it ahead (Cytodyn). It will take off; keep after it. Some investors want a fast return, but it takes time....
Dr BP would be happy not to see the word "trend" used in PRs. Something is either effective or not. Dr Yo: "Is leronlimab effective in mild to moderate patients?" Dr BP: "yes!" Day 3 results aligns with what we have been talking about since March. (clinical vs. MOA aligns)
Dr BP: M2M results, with unmet need, plus failure of all other drugs tested thus far, should result in FDA approval.
Dr Yo: final thoughts? Dr BP: IncellDX looking at leronlimab as it fits with regulating the effect in immune modulation based upon manipulation of dosage and other factors. Rantes study is HUGE and complex, must pick and choose areas to focus upon. Priority should be given to highest impact upon health vs business needs (profit). IncellDX will continue to dive into this research to identify more nuanced (my term) application of this drug (and others?) for treating various diseases. (I think he suggests an enormous, long-term development effort for leronlimab across many more indications. How can the drug be used to precisely manipulate or direct the immune response for specific indications?)
Dr BP: Cytdodyn has a strong argument to make with FDA for approval. FDA decides and we don't know what they'll do.
My take in summary: the science is solid and growing in strength. So, buy the company not the stock. This company has a tremendous future, though we don't know where the SP will be tomorrow or next month.
Saddle up! Get that hat down tight, son. And grip that rope... Give it a nod and let's go!
Points of interest (my paraphrase / interpretation):
Day 3 huge impact for M2M patients over and against placebo reported. If this data holds through the submission of data to FDA, it should be basis for approval. M2M patients can be released earlier, saving $$ and healthcare resources. The M2M patients ALL had symptoms, incl cytokines. All had benefit from leronlimab.
M2M achieved results that no other CV drug has experienced... That is significant. Seems reasonable to expect approval.
Did not measure viral load in M2M samples, not a part of the trial. Not included in the analysis. Would need to run the samples.
Key for drug's success is clinical outcome being aligned with MOA. M2M is showing this, along with supporting EIND experiences. Day 3 is a critical day for proof of immunological improvement. Day 3 is "game time". Establishing credibility.
FDA doesn't have time to do all the study of the MOA science; they want the statistical analysis to drive their decision. Too many other drugs / priorities.
Dr BP's paper to come out "very soon". Became aware of some "political stuff"; addressed it with editors and got it straightened out, or will be doing so. Been fully reviewed now, and awaiting final decision on publication. Dr P says he's reviewed over 100 papers himself, and his paper is solid and WILL be published soon. "It will see the light of day." 15,000 views of preprint have been logged.
Blood samples are coming in from all over the world for testing. (All recognizing the IncellDX work related to leronlimab) Many Drs in U.S. aware of and following leronlimab on social media. Dr Yo said this is due to Dr BP's advocacy and ability to explain the science. How can we get Dr BP out there to do more?
DrBP: What is needed is regulatory recognition / approval, along with published papers, which will ultimately get the word out and create the application of this drug to the need. (Implicit: awareness of the investment opportunity)
Example given: there are many stories of scientific findings ignored by public for years, and then it clicks. "It takes a while for people to get their arms around it." (Dr BP) Just keep talking about it. It needs to percolate over time. Some companies don't have big marketing teams to push it ahead (Cytodyn). It will take off; keep after it. Some investors want a fast return, but it takes time....
Dr BP would be happy not to see the word "trend" used in PRs. Something is either effective or not. Dr Yo: "Is leronlimab effective in mild to moderate patients?" Dr BP: "yes!" Day 3 results aligns with what we have been talking about since March. (clinical vs. MOA aligns)
Dr BP: M2M results, with unmet need, plus failure of all other drugs tested thus far, should result in FDA approval.
Dr Yo: final thoughts? Dr BP: IncellDX looking at leronlimab as it fits with regulating the effect in immune modulation based upon manipulation of dosage and other factors. Rantes study is HUGE and complex, must pick and choose areas to focus upon. Priority should be given to highest impact upon health vs business needs (profit). IncellDX will continue to dive into this research to identify more nuanced (my term) application of this drug (and others?) for treating various diseases. (I think he suggests an enormous, long-term development effort for leronlimab across many more indications. How can the drug be used to precisely manipulate or direct the immune response for specific indications?)
Dr BP: Cytdodyn has a strong argument to make with FDA for approval. FDA decides and we don't know what they'll do.
My take in summary: the science is solid and growing in strength. So, buy the company not the stock. This company has a tremendous future, though we don't know where the SP will be tomorrow or next month.
Saddle up! Get that hat down tight, son. And grip that rope... Give it a nod and let's go!
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